Category Archives: Healthcare Services

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

2019 PDA Europe Biomanufacturing Conference in Munich: new speakers announced

BERLIN, 14-Aug-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany. The following health authorities have confirmed speakers:

  • Danish Medicines Agency
  • Dutch Medicines Evaluation Board
  • European Medicines Agency
  • European Directorate for the Quality of Medicines & Healthcare (EDQM)
  • Swedish Medicines Agency

Mats Welin, Medical Products Agency, Sweden, and Dolores Hernan, European Medicines Agency, will provide an opening plenary talk on Accelerated Access and discuss the results of a 2018 EMA/FDA workshop on quality considerations for early access approaches. Those intrigued by Accelerated Access can learn more in the follow-up session, moderated by Martjin van der Plas, Dutch Medicine Evaluation Board. Welin and Hernan will participate in a panel discussion ending that session.

After a the first-day luncheon, Nanna Kruse, Danish Medicines Agency, will peel away some of the mystery surrounding the forthcoming International Conference on Harmonization (ICH) Guideline Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. In a parallel track, the Austrian Agency for Health and Food Safety (speaker TBD) will intrigue the audience with a review of challenges regulators routinely face with the advent of new vaccines and innovative biologics.

Bright and early on 4 September, the EDQM’s Gwenael Cirefice and the Dutch Medicines Evaluation Board (speaker TBD) turn the attention to ICH and advances in test methodologies. In a parallel track, Martjin van de Plas returns to the podium to review regulatory ideas regarding quality by design and control strategies. Hernan takes the mic as the conference’s last speaker to discuss EMA’s 2025 regulatory science strategy.

The meeting will close with a panel discussion including all the regulatory representatives participating.

Learn more about the topics that will be examined in-depth and/or to register. https://www.pda.org/global-event-calendar/event-detail/biomanufacturing-conference

Members of the press are welcome to apply for a press pass. https://www.pda.org/about-pda/press-pass-request-form

SOURCE: EuropaWire

2019 Red Herring North America Top 100 Winner: New recognition of OncoBeta’s success in developing and providing an innovative therapy for non-melanoma skin cancer patients

Pasadena, CA, U.S.A., 6-Jul-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta®, a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today, that it was honored as a Red Herring Top 100 North America Award winner recognizing the continent’s most exciting and innovative private technology companies. After being recognized with the Red Herring Top 100 Europe Award earlier this year, this is now the second recognition obtained by Red Herring.

The winners, celebrated at a special awards ceremony at the Westin Pasadena hotel, have been chosen from thousands of entrants, whittled down to hundreds making the trip to California. The ceremony, led by Red Herring chairman Alex Vieux, was preceded by two days of keynote speeches, discussions and finalist presentations.

Companies were judged by industry experts, insiders and journalists on a wide variety of criteria including financial performance, innovation, business strategy, and market penetration. Winners ran the gamut of verticals, from FinTech and Marketing to Security, IoT, and many more industries.

Red Herring’s editors have been evaluating the world’s startups and tech companies for over two decades. It gives them the ability to see through the industry’s hype to pick firms that will continue on a trajectory to success. Brands such as Alibaba, Google, Kakao, Skype, Spotify, Twitter and YouTube have all been singled out in Red Herring’s storied history.

“2019’s crop of Top 100 winners has been among our most intriguing yet,” said Vieux. “North America has led the way in tech for so many years, and to see such unique, pioneering entrepreneurs and companies here in California, which is in many ways the heartland of the industry, has been a thrilling experience.”

“What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Vieux. “Some of the technical wizardry and first-rate business models showcased here at the conference has been fantastic to learn about. We believe OncoBeta® embodies the drive, skill and passion on which tech thrives. OncoBeta® should be proud of its achievement – the competition was incredibly strong.”

“Being named as one of the Red Herring’s Top 100 North America award winner in addition to the Top 100 Europe is a great honor for us.” states Shannon D. Brown III, CEO of OncoBeta®. “The spirit of the award aligns perfectly with our team’s mission in the fight against non-melanocytic skin cancer (NMSC) with the Rhenium-SCT®.”

The complete list of the 2019 Red Herring North America Top 100 Winners can be found here in alphabetical order: https://www.redherring.com/2019-rhna-top100-winners/

Red Herring’s press release is available online at https://www.redherring.com/red-herring-2019-top-100-north-america-winners-press-release/

SOURCE: EuropaWire

EMA, MHRA and U.S. FDA among regulatory agencies participating at PDA’s 4th Annual European Meeting in Amsterdam

BERLIN, 10-Jun-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.

From the Max Planck Institute for Human Development, Felix G. Rebitschek will deliver the keynote speech, “Decision-Making Under Uncertainty.” Following him, the opening plenary “Regulatory Updates – Current Situation” will discuss understanding regulatory frameworks in an atmosphere of rapid change and provide the opportunity to participate in conversation with regulators and industry representatives.

Regulatory agencies sharing industry updates include the European Medicines Agency, U.S. FDA, WHO, MHRA and HPRA, PIC/S.

A series of parallel tracks will offer the chance to learn about topics ranging from virtual reality, data quality management, manufacturing technologies and much more.

Learn more about the topics that will be examined in-depth.

Registration (https://store.pda.org/Meetings/Login.aspx?ID=4520) can be completed until June 24.

Bona fide members of the press are welcome to apply for a press pass.

SOURCE: EuropaWire

2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference

BERLIN, 28-May-2019 — /EPR HEALTHCARE NEWS/ — The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.

Lithuanian University of Health Science professor Romaldas Maciulaitis will get the meeting off to a quick start with his presentation, “Development and the Use of ATMPs in EU/Lithuania.”

Following him in the opening plenary session is Alistair Gibb from the UK Medicines and Healthcare Products Regulatory Agency, presenting “ATMPs System-wide Challenges from Innovation to Uptake – Pragmatic Supportive Regulation and Standards.”

The Paul-Ehrlich Institute’s Isabelle Bekeredjian-Ding takes the podium after her British counterpart with, “From Individualized to Standardized Microbiological Quality Control in ATMP Manufacturing.”

The PDA EU ATMP Conference comes just a month after PDA’s successful Cell and Gene Therapy Conference in Long Beach, Calif., May 6 – 7. That conference drew 200 participants. Earlier this year, PDA published Technical Report No. 81: Cell-Based Therapy Control Strategy.

Go here to see the full speaker lineup.

Press passes are available here to bona fide members of the press.

SOURCE: EuropaWire

The interregional professional association for nuclear medicine in Hanau has become the first treatment center in Germany to offer the Rhenium-SCT® (SCT= Skin Cancer Therapy)

GARCHING N. MUNICH, Germany, 13-May-2019 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), is pleased to announce that the interregional professional association for nuclear medicine in Hanau now offers the Rhenium-SCT ® (SCT= Skin Cancer Therapy) as the first treatment center in Germany.

With approximately 50.000 outpatient examinations annually, the interregional professional association for nuclear medicine Hanau is one of the biggest nuclear medicine service providers in Hesse. The offered services include a variety of different modern treatment and diagnostic methods which are state-of the art in science and technology.

“Offering NMSC skin cancer patients a highly efficient, painless, innovative therapy with excellent aesthetic results was the driving reason to establish this treatment method in our clinic,” says Dr. med. Lutz-Hendrik Holle, Medical Director of Nuclear Medicine in Hanau.

“We are delighted that our innovative skin cancer therapy Rhenium-SCT® is now being offered by the Nuclear Medicine in Hanau and we are looking forward to this collaboration”, states Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “For us, this is an important step to offer the treatment method in addition to Italy, South Africa and Australia now also in Germany. In order to provide our treatment to as many skin cancer patients as possible, it is of course our goal to offer the availability of the therapy nationwide in Germany in the future.”

The global incidence of non-melanoma skin cancers has been drastically increasing over the past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. In Germany the number of newly diagnosed patients is about 200,000 annually and it is assumed that this number increases within the next years. To serve the increasing medical need for innovative therapies in this field and to improve the quality of patients’ lives, OncoBeta® GmbH has developed its innovative Rhenium-SCT® which only require a single application, applied in one single session with excellent aesthetic outcomes.

If interested, patients and doctors can either contact the interregional professional association for nuclear medicine in Hanau directly or OncoBeta® GmbH.

SOURCE: EuropaWire

GD E-BRIDGE™ EARNS FIRSTNET LISTED DESIGNATION

Ridgefield, New Jersey, 2019-May-02 — /EPR Network/ — General Devices (GD) has announced that, after following a rigorous review process, GD e-Bridge™ is now FirstNet Listed and available via the FirstNet App Catalog.

FirstNet – America’s public safety communications platform – features the first-ever App Catalog geared to first responders. This gives FirstNet subscribers a dedicated location to find meaningful new solutions that have been specifically reviewed for use with FirstNet services. Before any mobile solution can be added to the FirstNet App Catalog, it must pass stringent tests for security, relevancy, data privacy and more.

Achieving a FirstNet Listed designation means GD e-Bridge is a vetted and trusted solution for public safety, meeting FirstNet app requirements. Additionally, FirstNet subscribers will be able to experience the benefits of key FirstNet capabilities – like First Priority®, which enables priority and, for first responders, preemption – while using GD e-Bridge. FirstNet subscribers will also be able to take advantage of the GD e-Bridge solution while benefitting from the enhanced security provided by the FirstNet network core, which is the only physically separate network core dedicated entirely to public safety in America.

Out-of-hospital healthcare is changing, and mobile telemedicine is making a real positive difference. The emphasis now is providing the right care, at the right place and right time. This is especially true in rural regions, but also in the case of time sensitive, acute care issues everywhere like heart attack, stroke and sepsis.

“From the first medical contact by EMS in the field, the GD e-Bridge mobile telemedicine and workflow app provides data and team communications that shave precious minutes off lifesaving treatment,” said Curt Bashford, GD’s CEO.

The hospital ED is not always the appropriate destination for non-acute emergencies. The role of Mobile Integrated Healthcare and Community Paramedicine is growing. Plus, the newly announced HHS ‘Emergency Triage, Treat and Transport’ (ET3) program better aligns reimbursement incentives and enables appropriate on-site treatment and transport to alternate destinations, such as urgent care centers – provided they are managed with mobile telemedicine and telehealth support. That’s where GD e-Bridge also comes in and enables simply better, more cost-effective care.

Built with AT&T in a public-private partnership with the First Responder Network Authority, FirstNet is bringing public safety a much-needed technology upgrade to help them connect to the critical information they need – every day and in every emergency.

“Only highly secure, high quality, public safety relevant applications are added to the FirstNet App Catalog. And we’re pleased that GD e-Bridge is now Listed and available to FirstNet subscribers,” said Bob Sloan, chief operating officer, FirstNet Program at AT&T. “GD e-Bridge will bring public safety additional capabilities to improve decision-making, enhance situational awareness, help save lives and improve outcomes.”

“Through our work with first responders, we heard their need for innovative applications to assist with their lifesaving mission. FirstNet is helping to address these needs, and we are pleased to welcome GD e-Bridge to the FirstNet App Catalog,” said Mark Golaszewski, executive director of Technology and Innovation, First Responder Network Authority.

To learn more about GD e-Bridge, go to General-Devices.com. For more on FirstNet, check out FirstNet.com.

FirstNet and the FirstNet logo are registered trademarks of the First Responder Network Authority. All other marks are the property of their respective owners.

Via EPR Network
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Mr RICHARD GUILLAUME IS APPOINTED TO THE DIAFIR BOARD OF DIRECTORS

RENNES, FRANCE, 2019-Apr-08 — /EPR HEALTHCARE NEWS/ — DIAFIR, a medical technology company focused on the development, manufacture and sale of innovative diagnostic solutions in nonalcoholic steatohepatitis (NASH) and septic arthritis announces today the appointment of Mr Richard Guillaume to its Board of Directors.

Mr Guillaume has a wide experience of over 30 years in international management and operations in the pharmaceutical industry as well as in the medtech. Drawing on his experience and knowledge in the field of medical devices and diagnosis, Mr Guillaume will advise and help the Company in its development.

Alongside his role at Diafir, Richard Guillaume has been the General Manager of Echosens from 2008 until 2013. He was previously Executive Vice President Global Sales and Marketing at Blatchford, a UK medical device company. He was also member of the board. Prior, he held various positions such as Director Global Marketing of Abbott International in Chicago and Director Category Development Europe of Mead Johnson. Richard holds a Master in Business Administration from Poitiers University and a DESS in Marketing from Paris Dauphine completed by a general management program at INSEAD.

 

Via EPR Network
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GenieMD to Feature Award Winning AI-based Telemedicine Platform at HIMSS19

San Francisco, CA, 2019-Jan-24 — /EPR Network/ — GenieMD will be exhibiting at HIMSS19 in Orlando, Florida February 11-15, 2019. The GenieMD team will be showcasing their iVisit Telemedicine platform. GenieMD’s award-winning Telemedicine platform, driven by an AI engine, assists in the patient’s triage allowing for a streamlined consult with their physician through its HIPAA compliant text messaging, video visits and question-based asynchronous visits.

Patients are demanding convenience, expanded access and lower cost of health care. Doctors are overwhelmed with simple cases which take up most of their consult time. Clinics are struggling to manage costs in light of their patients increasingly use of alternative channels to seek treatment. To address these challenges, technology companies are innovating new ways for patients to gain access to providers. Government regulators are responding more favorably to the use of these methods including Telemedicine. Therefore, Telemedicine adoption is growing at a rapid pace.

“At GenieMD, our mission is to help improve the quality of human life by providing solutions that enable people to live healthier and longer.” – Dr. Soheil Saadat, CEO

The company offers a wide range of products and services designed to democratize healthcare globally.

Via EPR Network
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University of Pretoria Prof. Mike Sathekge is First in South Africa to Treat Non-Melanocytic Skin #Cancer Patients with Rhenium-SCT®

Garching n. Munich, Germany, 26-Nov-2018 — /EPR HEALTHCARE NEWS/ — OncoBeta® GmbH, a commercial stage Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanocytic Skin Cancers (NMSCs), announced today that Prof. Mike Sathekge from the University of Pretoria, Steve Biko Academic Hospital Nuclear Medical department and his clinical team has treated the first non-melanocytic skin cancer patients in South Africa with the innovative Rhenium-SCT® skin cancer treatment System. This next-generation radionuclide therapy technology applied by the nuclear medicine physician offers a new singles session, painless treatment for patients suffering from Basal Cell – and Squamous Cell Carcinomas (BCCs and SCCs).

The global incidence of non-melanoma skin cancers has drastically increased over the few past decades. Depending on the source, it is estimated that there are over 5 million non-melanoma skin cancer cases reported globally each year. Approximately 80% of non-melanoma skin cancers are basal cell carcinomas or squamous cell carcinomas with South Africa having one of the highest incidence rates in the world.

Prof. Mike Sathekge and his team at the University of Pretoria, Steve Biko Academic Hospital are focused on providing patients with personalized care using state-of-the-art technology that can deliver high-precision therapy and diagnostics with minimal side effects. The specialized team of experts in the nuclear medicine and medical physics, work closely with other disciplines within the university hospital, referring physicians, and other institutions, to ensure patients receive the best possible treatment for their specific type of cancer.

Martin Magwaza, CEO of Tautomer (PTY) LTD Oncobeta®’s distribution partner for the Rhenium-SCT® in Africa, is dedicated to providing South Africans with new innovative and effective therapies across the continent, coordinating with representatives from all levels of government and state for the health care landscape.

“The start of the Rhenium-SCT® in South Africa is a significant milestone in the international expansion of our ground-breaking treatment for BCCs and SCCs.,” said Shannon D. Brown III, CEO and Managing Director of OncoBeta® GmbH. “Our vision of bringing a revolutionary affordable skin cancer therapy to physicians and patients all over the world has come one step closer today”.

SOURCE: EuropaWire

Just For Diabetics Website Offers Hope for Pre-diabetics, Type 2 diabetics, and the Overweight

Research shows that the best time to take action to reverse pre-diabetes and type 2 diabetes is when you are at the stage of managing these conditions.

Vancouver, BC, Canada, 2018-Nov-06 — /EPR HEALTHCARE NEWS/ — November is world diabetes month. When people are diagnosed type 2 diabetic, the first line of defense is the use of prescription drugs in order to manage the diabetes. But what victims of pre-diabetes and type 2 diabetes are not aware of is that research performed by Just For Diabetics website founder, Ernest Quansah, shows that when patients are managing their pre-diabetes or type 2 diabetes, it is the best opportunity for them to reverse it and be weaned off the prescription drugs. The research results are evidence based. Many doctors and institutions now agree that this is the case. Recently, the University of British Columbia, in conjunction with Pharmasave, a drugstore chain, began offering obese people and type 2 diabetics a diet plan aimed at reversal of pre-diabetes and type 2 diabetes. The cost of their plan is $500 a month. The diet plan calls for no consumption of refined sugar, potatoes, fruit, fruit juices, sweet drinks of any kind, rice, bread, and consumption of cooked vegetables for lunch, cooked chicken breast for dinner and so on. Many of the participants are seniors, the overweight, or obese. After several thousand of dollars spent, many participants lose weight and their doctors take them off their diabetes drugs.

Quansah’s program includes a specialized diabetes exercise regime along with vitamin therapy and a carefully designed tasty menu cycle. He himself completely reversed his severe case of type 2 diabetes after compiling this program, which was the culmination of thorough research. This research included the advice of several physicians. Quansah, founder of Just For Diabetics and the author of Diabetics Journey says: “For several years, I have been educating people about how type 2 diabetes and pre-diabetes can be reversed through the program offered on my website. Now we see that one of Canada’s finest Universities and a drug store chain are doing the same.”

The website, justfordiabetics.com offers a free weight-loss program, a free diabetes reversal program, as well as an inexpensive paid program. The extensive program includes a full menu regime, exercise videos, tutorials, in addition to a cooking video demonstration, all for less than $180. Quansah wisely suggests that those on the program be monitored by their doctors.

Quansah’s research and findings have been published in the WebMD Diabetes magazine in the article “Secret recipe: How a Chef Cured His Type 2 Diabetes”, as well as on the WebMD website. There is hope for reversing pre-diabetes, type 2 diabetes (the type that does not require insulin injections,) and for overcoming being overweight.

“Misinformation about type 2 diabetes is rampant. For diabetics to heal, they need a complete change of attitude and way of thinking. This means, they should not just accept managing their condition, but rather, understand that they can be healed. Further, complacency about pre-diabetes leads to full-blown diabetes, which can lead to heart disease, blindness, liver failure, impotence, limb amputations and early death,” cautions Quansah.

Quansah has been asked to be guest speaker at the Diabetes and Healthcare Conference being held in Helsinki, Norway, in November 2018 and to be keynote speaker at the Diabetes Care Conference being held in Malaysia in May of 2019. His speech topic will include how to help diabetics heal and resultantly reduce healthcare costs.

Via EPR Network
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IBM Watson Market Study: IBM Watson services have been positively disrupting and reforming operations in the healthcare industry

DUBLIN 2, Ireland, 10-Oct-2018 — /EPR HEALTHCARE NEWS/ — IBM Watson Services continue to get significant traction from end-users, with over 72% respondents in Europe affirmative on using IBM Watson language services, according to a Fact.MR survey. The survey is part of the comprehensive research study on IBM Watson services market which tracks the adoption of this platform across key sectors. The Fact.MR survey also reveals that use of IBM Watson vision services attracted the minimum interest, with only 48% of respondents in Europe affirmative about using it.

Fact.MR’s IBM Watson services market survey gathered data from over 500 respondents in 10 European countries. These respondents represented large-scale, SMEs, and micro organizations, with a collective IT spending budget of over US$ 50 billion. The findings of the survey were in sync with the overall expectations and use of IBM Watson services, which are highly reliant on revenue generated from language services.

Growing Realization that Cognitive Technologies Can Empower Decision-Making 

The survey indicates that mitigating the gaps that exist in IT vendors’ execution from data collection to action remains the key concern of organizations. There is an increasing realization among IT vendors that cognitive technologies can empower decision-makers to make sense of colossal structured and unstructured data. The survey offers encouraging insights on the growing use of advanced analytics and cognitive computing in today’s data-driven economy, as over half of the respondents in the survey agreed to using insights- and speech-services of IBM Watson.

Request Sample of IBM Watson Services Market Report at https://www.factmr.com/connectus/sample?flag=S&rep_id=759

“Today, the requirements of organizations are multi-pronged – from gaining a holistic customer view to agile data-to-execution operations, organizations need to invest in cognitive computing and advanced technologies to stay competitive,” says Shambhu Nath Jha, Senior Consultant at Fact.MR and co-author of the study.

“IBM Watson services have been positively disrupting and reforming operations across sectors, especially healthcare. From screening patient’s structured and unstructured data to regulatory requirements and medications, IBM Watson services are witnessing extensive adoption in the healthcare sector,” added Mr. Jha. The growing adoption of IBM Watson services in healthcare is further substantiated by Fact.MR’s findings that the sector currently accounts for nearly 21% revenue share, representing a market value worth US$ 318 Mn.

Improved Business Agility and Seamless Customer Service Identified as Key Advantages 

The Fact.MR survey further reveals that improvement in business agility is the most prominent motivation driving investment in IBM Watson services. Nearly 84% of respondents currently using IBM Watson services said that there was a marked improvement in business agility since the introduction of platform in their organization. An additional 82% said IBM Watson services helped their organizations in improving and transforming customer service.

“Customer service has often remained a key concern for organizations; despite the proliferation of advanced technologies and pervasiveness of smartphones, nearly 50% of customer support calls remain unresolved,” says Shambu Nath Jha. “The integration of artificial intelligence (AI) can mitigate this challenge, and offer seamless support for Tier 1 queries. The system can also effectively gauge the queries that require human intervention, and escalate those queries to a customer support executive if necessary,” adds Mr. Jha.

Know the methodology behind the report 

https://www.factmr.com/connectus/sample?flag=RM&rep_id=759

Effective decision-making, handling colossal structured and unstructured data, and sales assistance are among the other key advantages of using IBM Watson services, according to the Fact.MR survey. “Effective decision-making entails a deep understanding of the unique needs and requirements of customers. Today, businesses are hard-pressed to understand the unique characteristics of their customers, and effectively map their existing and upcoming products to meet the overt and covert needs. IBM Watson can provide sophisticated recommendations that can facilitate effective decision-making,” Mr. Jha added.

Fact.MR’s report on the global IBM Watson services market projects a surge in investments to mitigate cybersecurity risks. According to Fact.MR, a majority of organizations have some level of cybersecurity apparatus in place. However, as Mr. Jha concludes, “tackling the potent cybersecurity threats will require a comprehensive ecosystem, rather than a symbolic front-line defense.”

The IBM Watson Services Market Report is Available for Direct Purchase at

https://www.factmr.com/checkout/759/S

SOURCE: EuropaWire

Study published in World Journal of Urology confirms Fotona SMOOTH® laser technology is a safe, effective & minimally-invasive solution for stress and mixed urinary incontinence

LJUBLJANA, Slovenia, 21-Sep-2018 — /EPR HEALTHCARE NEWS/ — The latest study published in the World Journal of Urology (Comparison between erbium‑doped yttrium aluminum garnet laser therapy and sling procedures in the treatment of stress and mixed urinary incontinence – https://doi.org/10.1007/s00345-018-2445-x) provides further confirmation that Fotona SMOOTH® laser technology is a safe, effective and minimally-invasive solution for stress and mixed urinary incontinence (SUI and MUI). The article, written by Dr. Nobuo Okui, compares Fotona’s minimally invasive IncontiLase® Er:YAG laser therapy with the more conventional TVT and TOT surgical sling procedures.

Asian Study Confirms Favorable Results of Fotona SMOOTH® Laser Therapy for Urinary Incontinence

In the study performed by Dr. Okui, 50 Japanese women were treated either surgically (tension-free vaginal tape – TVT or transobturator tape – TOT) or with a Fotona laser. The 1-h pad test, ICIQ-SF, and overactive bladder-symptom score were used to assess the patients before and 12 months after treatment. Laser therapy was performed by first applying a local anesthetic to the vaginal wall and then inserting a probe into the vagina. Laser irradiation was performed for 20 min with an Er:YAG wavelength of 2940 nm (Dynamis XS, Fotona) for a total of three treatments (alternating every month). Results of the 1-h pad test and ICIQ-SF showed comparable improvements in SUI in the sling and laser therapy groups, while some of the patients with MUI in the TVT and TOT groups showed exacerbation. In conclusion, the TVT and TOT procedures and the laser therapy are comparable for SUI; however, laser therapy is superior in terms of MUI and complications. The study thus once again confirms the safety and efficacy of Fotona SMOOTH® laser therapy for urinary incontinence.

Urinary Incontinence Treatment Options

Conventional treatment options for urinary incontinence are surgical, and include TVT or TOT sling procedures, which involve inserting a synthetic material. Problems often arise with artificial meshes that require new treatment methods. With the Fotona SMOOTH® Er:YAG laser thermotherapy (also known as IncontiLase®), the goal is to provide a minimally invasive therapy based on vaginal collagen hyperthermia followed by collagen remodeling and new collagen synthesis, which results in overall regeneration of aged or stressed vaginal tissues and subsequently greater support to the bladder.

Unique Fotona SMOOTH® Technology for Maximum Safety

Patient safety is the primary concern and, for this reason, the patented Fotona SMOOTH® technology holds a very unique position within the spectrum of gynecological treatment options. It is a non-surgical procedure (no incisions) and without implants or appliances. The Fotona SMOOTH® method of dual-tissue regeneration is completely non-ablative and therefore minimally invasive to the vaginal wall. The treatment involves an additional superficial heat-shocking mechanism of tissue regeneration, and a unique self-regulating safety feature. These dual-tissue regeneration characteristics of the Fotona SMOOTH® Er:YAG laser allow for an exceptionally high degree of safety and efficacy in thermotherapy of the vaginal wall. This is what makes Fotona SMOOTH® a significantly safer alternative to many widely used and more-invasive procedures.

Evidence-Based Laser Medicine

Over the past few years numerous (over 35) other studies on Fotona SMOOTH® laser therapy have been published by distinguished gynecologists from around the globe in some of the most trusted and renowned international scientific journals, all with favorable results (https://www.laserandhealthacademy.com/en/practitioners/recommended-reading/gynecology/). One such noteworthy clinical paper published in March 2018 by Dr. Adolf Lukanovic and Dr. Mija Blaganje is the first randomized controlled trial study (on 114 premenopausal parous women) to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy as an alternative non-invasive treatment of SUI and the improvement of sexual gratification (published in the European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018 (224): 153-158). The results from this study indicate that a single session of IncontiLase® treatment improves the impact of SUI symptoms on quality of life and sexual function in premenopausal parous women significantly better than placebo.

In another Asian study, Dr. Yi-Wen Tien et al. from the Chang-Hua Hospital in Taiwan examined the effects of laser treatment for female SUI on pad weight, urodynamics, and sexual function in 35 women (published in the International Urogynecology Journal. 2017; 28(3): 469-476). The study reveals that the effect of IncontiLase® treatment for mild SUI was moderate at the 6-month follow-up. Moreover, it improved LUTS, quality of life, and the sexual function of both partners. The authors conclude that the IntimaLase® procedure is very effective in the treatment of SUI and is not associated with any severe adverse effects.

Similarly, Dr. Yi-Hao Lin et al. from the Chang Gung Memorial Hospital in Taiwan obtained favorable results. Their study investigated the effects of non-ablative laser treatment on overactive bladder (OAB) syndromes, SUI and sexual function in 30 women with urodynamic stress incontinence (published in the Taiwanese Journal of Obstetrics & Gynecology. 2017 (56): 815-820). The results showed that IncontiLase® treatment can resolve SUI and coexistent OAB symptoms three months after therapy, while repeated laser therapy may be necessary after six months. The results also revealed that sexual gratification improved, while no major adverse effects were noticed.

The quantity and quality of the studies performed with Fotona SMOOTH® laser therapy is such that Fotona’s Dynamis has been cleared in the European Union for SUI (IncontiLase®), vaginal laxity – vaginal relaxation syndrome (IntimaLase®), genitourinary syndrome of menopause – GSM (RenovaLase®) and pelvic organ prolapse (ProlapLase®), giving women the option to choose a safer and less-invasive treatment alternative. In Asia, the Taiwan Food and Drug Administration has already cleared Fotona Dynamis for mild to moderate SUI, and the Singapore Health Sciences Authority has cleared the Dynamis for the treatment of SUI and GSM.

SOURCE: EuropaWire

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Dr. Christina Marrongelli chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference in Paris

Marrongelli selected for her expertise in Botanical Drug Development

LONDON, Jun-16-2018 — /EPR Healthcare News/ — As a leading expert in her field, Dr. Christina Marrongelli, PharmD has been chosen by the World Congress on Pharmacology & Chemistry of Natural Compounds to moderate their 2018 conference: Exploring New Trends & Innovations in Pharmacology and Natural Compounds. The conference is being held in Paris, France on June 18, 2018.

Dr. Marrongelli, who is an adjunct professor at the Medical University of South Carolina in the department of drug discovery and biomedical sciences will also present “Developing and Marketing Botanical Drugs in the United States”.

The United States, which has the largest pharmaceutical market in the world, demonstrates a strong demand for the use of botanicals as medicine. However, to date only two prescription botanical drugs are currently approved for use in the USA: Veregen® (sinecatechins) and Mytesi™Â (crofelemer).

Marrongelli attributes this disconnect between supply and demand to hidden barriers. She notes that with the worldwide herbal drug market is expected to reach nearly $86.74 billion by 2022, businesses must identify and address these barriers so that heterogeneous botanical drug products can obtain the approvals necessary to meet the consumers growing expectations and demands for botanical medicines.

To further explain the barriers to regulation of botanicals, Marrongelli points to the Botanical Drug Development Guidance for Industry from the U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER) that was last updated in 2016. According to publication, regulation of botanicals in the U.S. is different from regulation in the rest of world. The U.S. does not have a separate regulatory category for traditional or herbal medicines: A botanical product may be classified as a food (including a dietary supplement), drug (including a biological drug), medical device, or cosmetic under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Whether an article is a food, drug, medical device, or cosmetic depends in large part on its intended use.

To learn more about the issues and barriers to the development of botanical drugs, please contact Dr. Marrongelli at Marronge@musc.edu or DrM@pharmD.expert.

SOURCE: EuropaWire

Health Innovation Centre of Southern Denmark, Fraunhofer Institute Portugal and ProjectRay named the winners of the European Silver Economy Awards 2018

Winners of the first European Silver Economy Awards: Boaz Zilberman (ProjectRay), Anne Friis Hansen (Health Innovation Centre of Southern Denmark) and Ana Vasconcelos (Fraunhoder Institute Portugal)

BRUSSELS, Belgium, 20-May-2018 — /EPR Healthcare News/ — On Thursday May 3, the first edition of the European Silver Economy Awards has celebrated its winners under the patronage of Mariya Gabriel, Commissioner for Digital Economy and Society, and Markku Markkula, First Vice-President of the Committee of the Regions. The ceremony took place at the Committee of the Regions in Brussels and has been designed as an event that brings together key speakers and innovators from both the public and private sector.

The first prize in the category Public Authorities has been awarded to the Health Innovation Centre of Southern Denmark (Denmark) for their Generic Telemedicine Platform. The Fraunhofer Institute Portugal (Portugal) submitted a tool for fall prevention and detection (GoLive Solutions) and was the winning Non-for Profit Organisation. Introducing a smartphone solution (RAY Solutions) for visually impaired people, ProjectRay (Israel) has won in the category For Profit Organisation.

The Silver Economy Awards have been launched to recognise and reward innovative ICT solutions from all sectors, to raise awareness of the potentials of this section of the economy and to bring together European stakeholders under a common goal: supporting and improving the quality of life of older persons in society. On behalf of Commissioner Gabriel, Cabinet Member Manuel Mateo Goyet described the first Silver Economy Awards as representing a “milestone on our way towards becoming a truly age-friendly Europe”, and promoted the ceremony as “a unique occasion to send a very positive message on how we see the future of ageing” showing “the true value of collaboration in Europe”.

Celebrating the nine finalists and their dedication to making Europe an age-friendlier place, Markku Markkula, host and moral patron of the Silver Economy Awards, declares his acknowledgement: “I want them in my region”. More than 95 applications coming from 22 countries have been submitted for consideration in three awards categories referring to the type of organisation. Over 40 Silver Economy experts were involved in the three-staged evaluation process to determine Winner, Second and Third.

For more details on the winner entries and an overview of the final ranking of the first European Silver Economy Awards 2018 edition please visit www.silvereconomyawards.eu/sea/2017/awards#Winners.

SOURCE: EuropaWire

Alliance Life Sciences to present expanded portfolio of pricing & market access services at the World Pharma Pricing and Market Access Congress 2018

SOMERSET, N.J. / LONDON, UK, 19-Mar-2018 — /EuropaWire/ — Alliance Life Sciences, a leading global life sciences consulting, pricing data and technology provider, announced that it is a sponsor at the World Pharma Pricing and Market Access Congress 2018 taking place March 20-21 in London, United Kingdom. As part of the largest pharmaceutical commercialization organization that services more than 300 of the industry’s top pharmaceutical, biotech and medical device companies, Alliance will present its expanded portfolio of pricing and market access services. The focus will be on pricing and reimbursement data managed by PricentricOne and pricing governance, reference and tender pricing software manage by PriceRight.

Now in its 12th year the World Pharma Pricing and Market Access Congress brings together the most innovative leaders and organizations to discuss all aspects of evidence, access and pricing. This year’s event will feature over 150 speakers and a greater range of topics being covered including Big Data & AI, rare diseases, advanced therapies and other emerging, innovative areas.

Alan Crowther, President of Global Markets noted “Alliance Life Sciences is pleased to be a sponsor of the World Pharma Pricing & Market Access congress, particularly this year. We have made a number of investments in our people and infrastructure in Europe. Our acquisition by Water Street partners in 2017 allowed us to offer enhancements in our Market Access offerings too. Europe continues to be our focus market and World Pharma Pricing & Market Access congress is a great venue to showcase our expended capabilities”.

SOURCE: EuropaWire

Open House at Cedarview Rehabilitation and Nursing Care

Lebanon, OH, 2017-Dec-01 — /EPR HEALTHCARE NEWS/ — Community members and resident families are invited to attend an open house at Cedarview Healthcare Center on Dec. 5th from 5pm-7pm. The guests will be provided a tour of the facility and enjoy music and light refreshments at the event.

“We are all very excited at the facility for the changes and to share these improvements with our residents, the community and employees,” says Elliott Polsky, Administrator of CedarView Healthcare Center.

The renovations to the facility include our updated rehab unit, including a new rehab gym. The rehab unit has 8 private suites. The lobby was completely embellished including new furniture in the lobby and throughout the entire community. Cedarview HealthCare Center is an 83-bed skilled nursing home that caters to the residents of Lebanon.

Cedarview Healthcare Center is a skilled nursing community, located in Lebanon, Ohio, that offers a living alternative for those who need more support than they would receive in their home. The community offers a wide array of health rehabilitation, dietary, and social services for both short term rehabilitation and long-term stays.

Cedarview Healthcare Center has a Pulmonary Unit that is equipped to care for Resident’s with Trach’s, Vent’s and High Flow Oxygen needs. The facility is licensed by the State of Ohio Department of Health, and is staffed with a team that is equipped to meet the individual needs of each resident. Cedarview Healthcare Center is certified by both Medicare and Medicaid.

“I think when you visit you’ll be amazed at the modern surroundings and how accommodating the facility is for the residents,” says Lacrisha Crawford, Director of Admissions at Cedarview HealthCare Center.

For more information in regards to Cedarview Healthcare Center Pavilion please call (513) 932-1121 or visit our website at www.cedarviewhc.com.

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Connect. Integrate. Become One.

International Day of Yoga 21 June

Alpharetta, Georgia, US, 2017-Jun-13 — /EPR HEALTHCARE NEWS/ — The Heartfulness Institute will mark the International Day of Yoga on 21 June with public events in various locations globally (www.heartfulness.org). The events will be held at the Institute’s meditation and retreat centres and also at other community venues in partnership with civil society and yoga organizations and Indian diplomatic missions.

Every year on 21 June the United Nations invites the global community to celebrate the life-enhancing practices of Yoga. In establishing the International Day of Yoga, the United Nations underscored the need for building better lifestyles, recognizing that Yoga provides a holistic approach to health and well-being. The UN also called for the wider dissemination of information about the benefits of practising Yoga.

On the International Day of Yoga, the Heartfulness community, led by its youth, will bring together hundreds of thousands of people with the theme ‘Connect. Integrate. Become One’, in Chennai, Singapore, Hyderabad, Paris, New York, London, Toronto, Sydney and in other major metropolitan centres, as well as in many smaller cities, towns and rural areas globally. The core practices of Heartfulness are self-development tools for a modern lifestyle and for people from all walks of life. They include relaxation, heart-based meditation, cleaning and inner connection. There is no dogma or prerequisite of any kind, and no financial requirement; only the willingness and interest to try the simple, effective Heartfulness practices.

Since the beginning of 2017, the Heartfulness Institute has been offering free masterclasses in meditation, led by its global guide, Kamlesh Patel, also known as Daaji. More than one million people around the world, including educational, business and professional groups, have experienced the free masterclasses that are available at http://en.heartfulness.org/masterclass/.

Heartfulness is an approach to the Raja Yoga system of meditation called Sahaj Marg, founded at the turn of the 20th century and formalized into an organization in 1945. More than seventy years later, ongoing Heartfulness meditation training can be found at 2,500 schools and colleges, and over 100,000 professionals are meditating in over 3,000 corporations, non-governmental and government organizations.

Heartfulness Centres, known as HeartSpots, exist in 130 countries, supported by thousands of certified volunteer trainers. There are over 5,000 HeartSpots and over 300 retreat centres around the world where thousands of people gather to meditate (http://www.heartfulness.org/).

About Kamlesh D. Patel
Known to many as Daaji, Kamlesh D. Patel is the fourth guide in the Heartfulness tradition of meditation. He is a prolific speaker and writer, and you can read his latest writings at http://www.daaji.org/.

About Heartfulness Institute
Heartfulness Institute is a non-profit organization that promotes well-being and self-development through meditation, research and training. The Institute offers programs for individuals, local communities, corporates, government departments and the armed services, schools and colleges, rural communities and civil society groups worldwide, supported by certified trainers who are volunteers and who offer their time and expertise in this social cause.

For more information 
Email: info@heartfulness.org
Toll free numbers:India: 1-800-103-7726USA: 1-844-879-4327
Social Media: Heartfulness Facebook | Twitter | Google+ | YouTube | LinkedIN | Instagram

Websites: www.heartfulness.org, www.daaji.org
Durga Nagarajan, 180 Westchester Way, Alpharetta,Georgia 30005

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MEDLAB Series Europe, 13-15 Sep 2017, will cover Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Haematology

Spain, 04-May-2017 — /EuropaWire/ — After many years of operating successful MEDLAB events around Africa, Asia and the Middle East, Informa Life Sciences Exhibitions, the worlds leading publishing and exhibitions company, has announced that the MEDLAB Series will be expanding its presence into Europe. Taking place at the Barcelona Congress Centre in Barcelona, Spain, from 13-15 September 2017, more than 3,000 industry professionals are expected to attend Europe’s leading event for laboratory management and diagnosis.

With the European In-Vitro Diagnostics (IVD) market expected to reach USD 15.5 billion by 2024, a platform such as MEDLAB presents a huge opportunity for global laboratory industry leaders, including manufacturers, dealers and distributors, to make inroads into the European market. Housing international exhibitors and covering 2,000 sqm of exhibition space, MEDLAB Europe will give visitors from across the world an opportunity to access cutting-edge laboratory products, next-generation technology, innovative services and world-class educational content.

According to Tom Coleman, Group Exhibition Director, MEDLAB Series: “The launch of MEDLAB Europe is in line with our global expansion strategy for our MEDLAB series of events. The increasing prevalence of chronic diseases, rising geriatric population coupled with the rising awareness towards early diagnosis, has positioned the European IVD and medical laboratory market as a critical market for manufacturers, services providers, and dealers and distributors from across the globe. MEDLAB Europe will generate substantial value for our customers and partners by driving further product innovation and deeper engagement in these specific markets.”

Over the four-day event, MEDLAB Europe will also offer a multi-disciplinary congress tackling current challenges and developments key to the European market, and leveraging the true potential of laboratory testing to dramatically improve patient outcomes across the continent.

The conference programme covers five main tracks including Point of Care Testing (POCT), Histopathology, Lab Management, Microbiology and Haematology. From new methods of effective lab management to the development of techniques in detecting diseases, the conferences will also review the expanding role of the laboratory medicine and discuss partnership between a clinician and a lab professional in providing delivery of care to every patient.

“The scientific programme at MEDLAB has been carefully designed in collaboration with some of the brightest minds in the medical laboratory industry in order to have a real impact on improving the health and wellbeing of patients across the region,” said Coleman.

For more information about the MEDLAB Europe Exhibition & Congress, please visit: www.medlabeurope.com.

SOURCE: EuropaWire

Multispectral Optoacoustic Tomography (MSOT) can now more reliably detect early stages of inflammation

GERMANY, Mar-30-2017 — /EPR HEALTHCARE NEWS/ — Ulcerative colitis and Crohn’s disease are the most common inflammatory bowel diseases (IBD). Globally, more than 4 million people suffer from recurring inflammation of the intestinal mucosa. To date, non-invasive methods have not been able to detect these forms of IBD reliably. Researchers at the University Hospital Erlangen (Germany) have now shown for the first time how Multispectral Optoacoustic Tomography (MSOT) can more reliably detect early stages of inflammation when compared with other non-invasive diagnostic methods. These results have recently been published in the New England Journal of Medicine.

Evaluating the inflammatory activity of the intestines early and accurately helps to prevent complications associated with IBD and guide an optimal therapy regime. Currently, doctors frequently rely on an invasive endoscopy procedure to assess the intestinal mucosa of patients with IBD. Additionally, non-invasive imaging methods are increasingly used in the clinic. For example, ultrasound allows clinicians to examine the structure, thickness and blood perfusion of the intestinal wall with changes in perfusion patterns indicating an onset of inflammation.

“With the MSOT procedure, we additionally use laser light, by which we can detect inflammation earlier than previously possible with ultrasound”, explains Prof. Dr. Maximilian Waldner, Professor at the University Hospital Erlangen. “The earlier we detect signs of an upcoming flare – i.e., a change in blood content – the quicker we can react and start a preventive treatment”. The MSOT technology was developed by iThera Medical in Munich, and was first used on IBD patients last year.

The researchers of the University Hospital Erlangen have recently published their results in the renowned New England Journal of Medicine. “We examined 108 patients with Crohn’s disease using the MSOT technology and compared the results to established non-invasive diagnostic procedures as well as endoscopy and histology”, says Prof. Waldner. “We were able to demonstrate that hemoglobin values in the tissue measured with MSOT indicate very accurately the inflammatory activity in the intestines. The method appears to be superior to other non-invasive procedures, as MSOT for the first time was able to detect even low levels of inflammation without having to perform endoscopy”.

Dr. Ferdinand Knieling, a physician at the University Hospital Erlangen, adds: “We are hoping that this principle can be applied to many applications and, in particular, also be used to enable safe evaluations of children and adolescents. With this new examination method, many of the currently invasive procedures might become obsolete.”

In optoacoustic imaging, the physician scans the intestines transabdominally through the skin, applying pulsed laser light in the near-infrared region. The energy of the light absorbed in tissue is converted into acoustic signals which are then acquired by an ultrasound detector. Christian Wiest, CEO of iThera Medical, comments: “MSOT is a new diagnostic imaging modality that can detect changes in tissue composition associated with a variety of diseases, without the use of contrast agents. The technology has already been applied in other clinical feasibility studies, e.g. for the detection of melanoma metastasis in sentinel lymph nodes or for the assessment of suspicious breast lesions”.

The results of the IBD study at the University Hospital Erlangen were published on March 30th 2017 in the New England Journal of Medicine (Volume 376, Issue 13, pg.1292-1294).

SOURCE: EuropaWire

Five Years After Iraq War’s Official End, a New York Community Is Still Healing

NEW YORK, NY, 2017-Jan-14 — /EPR HEALTHCARE NEWS/ — As the Iraq War’s official end in December 2011 marks its fifth anniversary, many questions remain on its fallouts. New York’s French-American community is one of them, as it remembers its blacklisting when France opted out of attacking Iraq.

Choosing diplomatic pressure rather than “shock and awe” ignited fury for many in New York. The call for anti-French boycotts resonated in tabloids as pictures of New Yorkers spilling wines in gutters vied with accusations of an ally’s betrayal and cowardice. Information can be found by searching for “New York’s anti-French boycotts and Iraq,” and “Freedom fries.”

How effective were the boycotts? “Very much so, even devastating,” says French consulate’s official physician and mental health coordinator at the time, Gérard Sunnen, MD, “the French-American community of New York was stunned by their virulence and persistence. Why, many wondered, did they materialize only in New York, in striking contrast to the rest of the country?”

“Targeted were all manner of French-American businesses, from Air France to bakeries, as rosters of marked companies circulated widely. Earliest felled were restaurants, whose sales plummeted by as much as half. Like dominoes, they closed their doors, dismissing their workers. Called by many the “consulate’s darkest hour,” it went on for interminable months, years, and still resonates today.”

“As layoffs mounted,” Dr. Sunnen added, “so did their mental health consequences, from all manner of stress reactions to self-destructive depressions. And workers suddenly out of work could not find employment because no one would take them. The consulate’s social services department work load soared to levels never attained before.”

Faced with this onslaught, the New York State Department of Health (NYSDOH) was repeatedly contacted to lend the community its medical and mental health assistance. In addition, New York State and city top officials were insistently asked to add their voice to call off the boycotts. All appeals remained unanswered and, for reasons of non-assistance and abandonment of responsibility, this matter was eventually reported and filed in New York and Federal courts.

Dr. Sunnen, who also cites his experience as a Vietnam-era U.S. veteran, concludes, “history needs constant reckoning, otherwise it can remain a fable. These events are now brought to light so that long-term allies can better understand and appreciate the meaning of their special relationship.”

References:

Gérard Sunnen, MD, www.triroc.com/sunnen
Supreme Court, State of New York, No. 102194/2012
U.S. District Court, Southern District of NY 12 Civ. 3417
U.S. Court of Appeals, 2nd Circuit 13-465cv
U.S. Health and Human Services (HHS) 1:13-cv-1242
New York State Division of Human Rights (NYSDHR) No. 10181422
National Transportation Safety Board (NTSB) No. DCA96MA070

Contact-Details: Gerard Sunnen, MD
gsunnen@aol.com
www.triroc.com/sunnen

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