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.
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.
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.
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.
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.
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”.
DUBLIN 2, Ireland, 30-Oct-2018 — /EPR HEALTHCARE NEWS/ — Fact.MR has recently announced the launch of a new research study that delivers key market insights on kidney stone management management devices. The comprehensive report on kidney stone management devices market offers actionable intelligence, offering volume and value projections for a 10 year timeline (2018-2028).
Free sample of the kidney stone management devices market report is available on the below link.
United States remains the largest market for kidney stone management devices, accounting for over 88 percent of global sales in 2017
Eastern Europe and United Kingdom led demand for kidney stone management devices in Europe during 2018 and the trend is likely to continue in the future as well
Sales are encouraging in EU-4; growth is relatively slower than UK and Eastern European countries. EU-4 is likely to create significant opportunities for market players
Hospitals are the key sales channel, accounting for nearly 50% of total sales in 2017
Higher end user preference for lithotripsy devices, particularly extracorporeal variants prevails – lithotripsy devices will remain the top-selling segment in 2019 and beyond
Lithotripsy Devices Lead the Rally
Fact.MR reveals that sales of extracorporeal lithotripsy devices accounted for over 73 percent of the lithotripsy sales and over 60 percent of overall kidney stone management device sales in 2017, surpassing those generated from ureteroscopes and nephroscopes.
The demand for lithotripsy devices across developed countries of the United States and the EU-4 is projected to expand at a significant pace in the coming years. Sales of kidney stone management devices in United States alone are likely to cross US$ 200 Mn by end of 2018-end, maintaining the status quo of the country as the most attractive market.
The US remains a lucrative market for stakeholders, reflecting a 1.5x lead in sales over EU-4 combined and a 1.2x lead over China, India and ASEAN in 2018.
Medical Tourism Hubs in Asia: The New Growth Frontiers
Kidney stone management devices are likely to witness increasing traction among emerging economies in the Asia Pacific, such as China and India, albeit at a lower base. China remains lucrative, maintaining a 1.5X lead over India in 2018. India and ASEAN currently account for less than 10% share of the global market; however, opportunities abound as these countries position themselves as global medical tourism hubs.
For direct purchase of the kidney stone management devices market report, please click on the link below:
DUBLIN 2, Ireland, 18-Oct-2018 — /EPR HEALTHCARE NEWS/ — The European home diagnostics industry is realigning to foster integration with the broader customer-centric healthcare services. Growing consumer preference for home-based diagnostics, combined with innovation in online platforms, is creating sustained opportunities in this dynamic landscape. Riding on the coattails of these factors, the US$ 1.4 billion Europe home diagnostics market is likely to grow at 3.4% CAGR during the period 2018-2026.
Consumer Preference for Non-Invasive Glucose Monitoring Devices Still Remains Unmet
Glucose monitoring kits and devices remain the top-selling product, accounting for over 80% revenue share of the Europe home diagnostics market. The burgeoning demand for home-based glucose monitoring devices and kits can be attributed to growing prevalence of diabetes in Europe, which is increasing across all ages according to the WHO. The Fact.MR study opines that digital devices will remain the preferred choice over cassettes among European consumers.
The broader trends pertaining to non-invasive and painless diagnostics are driving innovation in glucose monitoring device development. According to the Fact.MR study, non-invasive glucose monitoring devices are likely to witness increasing penetration in Europe, albeit at a slow pace. The report also finds that broader innovation in non-invasive devices can drive healthcare consumerism across Europe.
The Fact.MR study remains optimistic on the future growth in Europe’s home diagnostics market, however, challenges prevail. “Self-testing, especially for people with type 1 diabetes, who require daily or frequent testing, remains a painful and inconvenient process. Over the decades, the innovation in glucose monitoring devices hasn’t really addressed the invasive part of the self-testing”, says Mr. Santosh Kumar, Senior Consultant at Fact.MR. “There is an urgent need for non-invasive glucose monitoring testing,” adds Mr. Kumar.
The Fact.MR study finds that home diagnostics manufacturers are aware of the evolving demand. Investment and research into developing minimally or non-invasive home diagnostics devices is gaining ground. “The realization that digital, and non-invasive devices are the future is dawning upon manufacturers. Market leaders, such as Siemens Healthcare and Abbott Technologies are leveraging wearable technologies and IoT to develop innovative products,” says Mr. Kumar.
Growth in Pregnancy and Ovulation Predictor Test Kits Sales Encouraging
Although glucose monitoring devices and kits will account for the majority of sales, encouraging trends in other self-test kits continue to complement market growth. Pregnancy test kits and ovulation predictor test kits are likely to witness surging demand, as an increasing consumer base feels confident about self-testing. Gains are also encouraging, albeit miniscule, in other home diagnostics products, such as urinary tract infection kits and male infertility test kits.
UK Maintains its Numero Uno Position, Germany and France Remain Lucrative
The Europe home diagnostics market remains concentrated in the UK, Germany, and France. These three markets collectively account for a market share of nearly 60% revenue share of the Europe home diagnostics market. The Fact.MR study opines that these three markets will witness increasing proliferation of next-gen home diagnostics devices.
Fact.MR study on the home diagnostics market brings interesting insights to the fore. According to the report, UK remains Europe’s largest market for home diagnostics, with revenues to the tune of US$ 280 million in 2017. The study opines that UK will maintain its numero uno position throughout the course of the forecast period 2017-2026. Germany and France will follow suit, however, sales will grow at a sluggish pace in the former.
The report also finds that home diagnostics devices that use urine and blood for testing will continue to remain pervasive in the Europe home diagnostics market. Samples devices and kits that use semen and breath are expected to witness growth during the course of the forecast period.
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.
“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.
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
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.
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™ (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.
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.
Los Angeles, California, 2018-Mar-26 — /EPR HEALTHCARE NEWS/ — Bristl combines proven science of light therapy with sonic vibration to improve oral care. The company also offers a subscription service to replace brush heads, so having the best oral health is also convenient.
Available on Kickstarter on Monday, March 26th at 9am (PST)
The combination of Bristl’s features, convenience, and style make for true market disruption:
Visible Red light (620–750 nm in wavelength) has been clinically proven to heal gum tissue and prevent inflammation. The same technology is often used in skincare; Bristl is bringing it to the everyday tooth brushing routine.
Visible blue light (450–495 nm in wavelength) has been clinically proven to kill and prevent oral bacteria that causes gingivitis and other gum disease. This safe and natural blue light is proven to be effective, and Bristl is proud to bring it to market.
Get Rid of Plaque
Bristl has three sonic vibration modes: regular, gentle, and off. Sonic vibration is recommended by dentists as it has the highest cleaning ability without damaging gums. The brush head is also particularly designed to reach in crack and crevices while letting light pass through the bristles.
A Few Stats
According to a study published in the Journal of Periodontology and Implant Science (Vol. 44: pp. 280-287), Bristl’s technology (even with only red light) was effective in achieving the following:
86% reduction in bacteria that causes destruction of tooth supporting tissue
117% improvement in PPD (Periodontal Pocket Depth) which indicates gum health
80% improvement in CAL (Clinical Attachment Level) which is another metric for gum health
The Bristl Science team consists of a group of innovators and scientists looking to use advanced technology to improve everyday lives. While we of course wish to build a successful business, we are doing so responsibly; Bristl has committed to donating a percentage of every sale to America’s Toothfairy to provide underserved children with dental care. Whether a customer or an underserved child, we’re on a mission to maximize oral health everywhere.
This is just the beginning. The Bristl Science team will work tirelessly to innovate and build products that improve lives, maximize health, and promote good. The Bristl light therapy toothbrush is just the first step toward a healthier future.
Clinical backing, photos, founders quotes, and more information can be found in our Media Kit: http://bit.ly/2HtKTJ8
BASEL, Switzerland, Aug-28-2017 — /EuropaWire/ — Global brand leader Invacare brings next generation technology to powerchairs, following extensive trials and consumer-led insights. Touch screen technology is used daily on devices such as smartphones and tablets and thanks to Invacare, this smart technology has now been encompassed into powerchairs.
The innovative REM400 remote has an impressive 3.5” colour touch screen that puts the user in complete control. Its features include:
• Swipe or tap operation
• Direct or menu navigation access to profiles and functions
• Adjustable brightness
• Glove mode setting
• Screen lock out function
• Configured for left or right handed use
And it doesn’t end there. The REM400 has built-in Bluetooth which allows connection to PC’s, laptops and Macs. Its integrated mouse mover with on screen mouse clicks lets users connect to their world through their remote.
One of the great benefits of a touch screen remote is that there are no fixed buttons. This makes the REM400 suitable for those with more complex physical and cognitive needs.
To see the REM400 in action, checkout the new video.
CARDIFF, United Kingdom, Aug-24-Aug-2017 — /EuropaWire/ — Global brand leader Invacare is once again raising the bar in the powerchair market, following on from the successful launch of the LiNX control system last year. Invacare has taken the smart technology a step further with a new touch screen remote, in-built Bluetooth technology, enhanced programming features and a range of specialist controls, all available on the remarkable Invacare LiNX powerchair range.
Touch screen remote
Introducing next generation technology to powerchairs, Invacare is pleased to present the REM400 remote with its 3.5” interactive screen that requires minimal force to operate. Following extensive customer-insight research, this innovative remote can be configured to a users’ physical and cognitive ability, thanks to its extensive functional capabilities. Also available is a REM500, a display only version of the REM400. Both remotes can be used with a wide range of specialist controls.
The REM400 and REM500 controls have built-in Bluetooth technology to allow users to connect to their PC, Mac and compatible Android devices that have built-in HID functionality.
Enhanced programming features
The LiNX system now allows professionals to mix and match the drive, seating and environmental controls in order to customise the display to suit the user’s lifestyle. E.g. The profiles can be customised by names such as Home, Outdoor and Work, with functions specific to each one. Profiles can also be set by user input options i.e. head control.
Another new feature is the ability to adjust the joystick commands. The basic commands on a powerchair are forward, reverse, left and right but there are also other commands such as tilt, recline, lights, horns etc. to consider. The REM400 and REM500 allow these commands to be changed to suit the user, based on frequency or even by accessibility.
To maximise a user’s control and independence, the REM400 and REM500 allow a selection of specialist user inputs to be used on Invacare’s remarkable powerchairs. They range from head controls, chin controls, Sip ‘n’ puff systems, joystick options, proximity switches and dual controls, allowing Invacare to provide a control solution for many powerchair users. To help professionals select the best control for a powerchair user, Invacare has put together a useful app with five simple steps to assist with the process. Take a look at the app by visiting www.linx4you.com plus it can downloaded from the Google Play Store and Apple App Store.
TDX SP2 base updates
The above offering is available on all Invacare LiNX powerchairs, with a selection of the specialist controls only compatible with the TDX SP2 Ultra Low Maxx – and it is with this chair that Invacare is now able to fully enter the complex rehab market. For more information on the TDX SP2 Ultra Low Maxx, visit www.invacareULM.com. As well as feature heavy, the TDX SP2 base itself can be customised thanks to the 10 contemporary shroud and rim insert options available which sit nicely on its new black tyres and castors. There is a new single sided fork option on the front and rear castors.
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).
Cambridge, England, 2017-Feb-14 — /EPR HEALTHCARE NEWS/ — Resveratrol and lycopene are the compounds known for anti-ageing and cardio-protective properties. Mediterranean diet based, among others, on consumption of big quantities of lycopene-rich vegetables coincides with a longer lifespan, lower incidence of CVDs and reduced occurrence of some forms of cancer among the population of Mediterranean region. High resveratrol consumption is considered a factor in “French Paradox”, where epidemiological data show low incidence of CVDs, despite high consumption of saturated fats. Consumers have enormous choice of food supplements including lycopene and resveratrol, but key information is often missing: what happens to the substance once consumed and how much of it is really absorbed?
Resveratrol – the powerful anti-ageing, antioxidant polyphenol
Resveratrol is a phytochemical from polyphenols family, compounds known for their antioxidant properties. It is produced by plants in response to different stresses from their surrounding environment and found mainly in the peel and seeds of red grapes, also in peanuts and berries. High resveratrol consumption is considered a factor in “French Paradox”, where epidemiological data show apparent disconnect between the incidence of cardiovascular diseases in French population and high consumption of saturated fats. It is thought to be related to high consumption of red wine that contains resveratrol. There is significant scientific research on the beneficial effects of resveratrol relating to anti-ageing and longevity – activation of sirtuin enzymes, support of mitochondrial metabolism, protection of telomeres, antioxidant properties. It also supports cardiovascular health and influences glucose metabolism management.
Lycopene – great contributor to healthy skin
Lycopene belongs to family of plant-derived substances – carotenoids. Due to their strong antioxidative properties carotenoids help protect plants from oxidative damage caused by various stressing factors. Scientific interest in lycopene originates from the phenomenon of the Mediterranean diet and its’ cardio-protective and longevity promoting properties. The Mediterranean diet is based, among others, on high consumption of tomatoes and other vegetables that contain high levels of lycopene and other carotenoids. The population of the Mediterranean region has a longer lifespan, lower incidence of cardiovascular diseases and lower occurrence of some forms of cancer. Because of its’ antioxidative properties lycopene helps fight against free radicals in the skin, reduces its’ sensitivity to UV radiation, reduces mitochondrial DNA damage, lowers the risk of heart diseases.
Carocelle® presents best in class lycopene and resveratrol anti-ageing supplement
The main challenge of resveratrol supplementation remains its’ bioavailability. As quickly as it is absorbed from intestinal tract to bloodstream most of it is transformed into inactive compounds. New Carocelle® Lycopene & Resveratrol formulation delivers superior bioavailability, proven in clinical trials. Carocelle® technology makes resveratrol over +500% more bioavailable than other products on the market and provides its’ outstanding concentration that would normally be difficult to obtain from other available sources.
Pharmacokinetic tests for Carocelle® Lycopene have also confirmed 2x higher concentration of lycopene in the bloodstream (bioavailability) in comparison to reference brand available on the market, with the same dosage of the compound.
Carocelle® Technology behind compounds’ superior bioavailability
Vesicle-micellisation helps carotenoids become more resistant to degradation in the highly acidic stomach environment. This ensures that more active lycopene and resveratrol can pass to the intestines and be absorbed. The vesicle-micelle format is easily transformed in the intestines by bile acids to the mixed micelles. This guarantees optimal absorption of fat-soluble ingredients, like lycopene and resveratrol. The result is increased delivery of active lycopene and resveratrol to the intestine for maximum absorption, improved bioavailability and remarkable bioactivity. Chaperone compounds in Carocelle® Lycopene & Resveratrol vesicle-micelles additionally contribute to increased bioavailability of both lycopene and resveratrol.
There are currently 3 SKUs within Carocelle® range:
Carocelle Cambridge Micelle Technology™ was founded in 2015 in collaboration with UK biotech firm Lycotec, headed by Dr. Ivan Petyaev. The company invents proprietary formulations and products that are scientifically tested and proven in laboratories in Cambridge, UK. Carocelle Cambridge Micelle Technology™ has its headquarters in Cambridge and operates a network of partnerships with research and commercial partners around the world.
DR. IVAN MIKHAILOVICH PETYAEV, MD, PHD
Dr. Petyaev is a medical doctor, researcher and author of scientific publications and inventions with applications in diagnostics, analytics, prevention and treatment of a variety of diseases. He spent his research years at MRS and Cambridge University in the Department of Pathology. To take his discoveries into innovative healthcare products he left University and set up his own company, Lycotec Limited. Dr Petyaev has wide experience of driving his innovations through the product development phase, clinical validation and in the setting up of industrial production of the successful prototypes. His projects have been supported by Cambridge University, the MRC, Papworth and Addenbrooke’s Hospitals, the British Heart Foundation, the Department for Trade and Industry and the Eurostars Eurica Project.
Vilnius/Lithuania, 2016-Oct-18 — /EPR Healthcare News/ — ZIVE smart radiation monitor has reached the final of Elektra Awards 2016, a big influential contest for the electronics market players. This device designed by R-NOX startup with the assistance of Promwad Electronics Design House was named one of six best innovative products of Europe exploiting the Internet of Things potentialities.
ZIVE is a portable radiation monitor of the next generation that can connect to smartphones and tablets via Bluetooth. It’s the first device of professional level designed for common people. It has a user-friendly interface, a Geiger-Muller counter, and a low market price comparing with other high-precision radiation monitors.
ZIVE radiation monitor measures gamma rays, ionizing radiation, and X-rays. Differentiating features of the device:
Calibrated by accredited European laboratories (CE).
High accuracy at a lower price in comparison with other similar devices.
“Smart monitor” mode that provides users with specific health and well-being advice: how to interpret the measurements and reduce the risks.
Working with maps to create eco-routes: save radiation spots, find cleaner routes.
The collected ZIVE data is used for the real-time global map of radiation contamination.
Roman Pakholkov, Promwad’s CEO and R-NOX’s mentor, says that the data collected by ZIVE users is stored in the eco-platform, which is becoming the most detailed in the world. This platform allows accelerating the innovations development for the environmental management and can be integrated into other devices and applications via the open API.
To date, R-NOX has developed partnerships with the largest tour operator in the Chernobyl Nuclear Power Plant Zone of Alienation; Greenpeace; companies and organizations in Japan, Finland, Singapore, and other countries.
Promwad continues its work in supporting new electronics design projects in the IoT field. The company believes in the high potential of this popular trend and are ready to share their experience in the development and manufacture of electronic products for the global consumer electronics market.
The best companies of Elektra Awards 2016 will be announced on Thursday, 1st December, at the awards ceremony taking place in The Ballroom, Grosvenor House Hotel, London.
+370 (5) 214 12 44 ex.227
Systech will be part of Sharp’s panel discussion addressing delegates on the theme of “Serialization: Optimizing Your Supply Chain Means Optimizing Your Partners.” The presentation will explore the critical path to supply chain readiness, risk assessment, benchmarking and serialization risk mitigation options. The briefing will take place in the Pharma Insight Briefing room on Tuesday, 4 October 2016 at 11:30am CEST.
Systech will also showcase its UniSeries™ serialization software offered as an integrated solution within Autajon’s exhibit booth #2P16 (Hall 2).
CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, will host more than 36,000 visiting pharma professionals from 4-6 October at the Fira Gran Via, Barcelona, Spain. More than 2,500 exhibitors from 150+ countries gather at the event to network and take advantage of more than 100 free industry seminars. Every sector of the pharmaceutical market is represented under one roof, this year in a new location in Barcelona.
With thousands of implementations across the globe, Systech is the world’s most trusted brand protection expert, and its UniSeries offering is the industry standard for serializing products. UniSeries is offered as an integrated solution with both Sharp Packaging and Autajon Group’s hardware. Systech’s patented, configurable software offers manufacturers the flexibility to adapt to new regulations without extensive reworking or revalidation, thereby reducing implementation, training and support costs.
“We are recognized as the world leader in serialization and brand protection,” states Manfred Voglmaier, Senior Director Sales Europe, Systech International. “With more than 30 years of experience in providing highly configurable solutions for serialization across a variety of industries ― along with our partners Sharp Packaging and Sinel ― gives us a unique insight for this panel.”
Systech’s products are in greater demand than ever before since it is estimated that over 15,000 production lines for prescription medication in Europe must be fitted with a serialization system over the next three years. The European Commission adopted a regulation on October 2, 2015, under which the serialization of prescription medicine packages will become mandatory in all EU countries by 2019.
Show exhibit hours are on Tuesday, 4 October – Thursday, 6 October. Systech representatives will be available in the Sharp Packaging booth #3L56 (Hall 3) during the event, as well as in the Autajon booth #2P16 (Hall 2). They will showcase Systech’s software solutions on sample packaging lines and via live demos throughout the event.
Join The Anniversary Celebration of the Fastest-Growing Organization In The Cannabis Industry
Santa Rosa, CA, 2016-Jun-17 — /EPR HEALTHCARE NEWS/ — It has been 20 years since California pioneered the nation in legalizing medical cannabis with Prop 215. Now California makes up 49 percent of the nation’s robust cannabis economy. California’s cannabis scene has exploded like the Wild West and there’s one more reason to celebrate. Sonoma County’s Canna-enthusiasts are invited to join Women Grow to mark its 1-year Anniversary with a celebration and award ceremony to honor ‘The Godmother of Cannabis’, Lynnette Shaw.
Women Grow is a national organization that seeks to connect and empower women in the legal cannabis industry and the group’s Sonoma County Chapter is excited to share their achievements. In the past year, the Chapter brought in 23 industry leader speakers and panelists, of whom 21 were women and 2 were men. Speakers have included: Amanda Reiman, Manager of Marijuana Law and Policy at Drug Policy Alliance, Samantha Miller, President and Chief Scientist at Pure Analytics, Ellen Komp, Deputy Director at California NORML and Jazmin Hupp Co-Founder/CEO of Women Grow.
“The cannabis industry’s future is held in our hands,” says Chapter Founder and Chairwoman, Ilana ‘Sugar’ Laytart. “We are currently writing the history and HER-story books and this event’s celebration is to acknowledge our commitment and perseverance in this movement.”
The celebration takes place on Thursday, July 7, from 6pm to 10pm at Annie O’s Music Hall in downtown Santa Rosa. “Celebration Attire” is suggested. Early-bird tickets cost $25 and can be purchased through Universe.com.
When: Thursday, July 7th, 6pm-10pm Where: Annie O’s, 120 5th Street, Santa Rosa Cost: EARLY BIRD $25
DOOR $40 CASH ONLY Event Highlights:
Terpenes 101 + Aroma Bar Presentation with Monica Fine of Absorb CBD and The Seasonal Apothecary.
Award Ceremony Honoring Lynnette Shaw, presented by Ilana ‘Sugar’ Laytart and Elaine Holtz.
Dessert Bar, DJs & Dancing, Giveaways, Snacks & Beverages and Cash Bar
Interested in being a sponsor? Email email@example.com
Financial assistance may be available. Email firstname.lastname@example.org to inquire.
This is a 21+ event and a non-consumption event.
Women Grow connects, educates, inspires and empowers the next generation of cannabis industry leaders by creating programs, community and events for aspiring and current business executives in the cannabis industry. Women Grow is the fastest “growing” network of female-forward cannabis businesses and the largest networking organization in the cannabis industry. You don’t have to be a current professional in the cannabis industry to join. The Sonoma County Chapter is run by Founder and Chairwoman Ilana ‘Sugar’ Laytart and Co-Chair: Joyce Williams.
While events are women focused, their networking series welcome and attracts both men and women to connect. Women Grow Networking Events occur the first Thursday of every month in Sonoma County. Website: www.womengrow.com.
Contact-Details: Nancy Birnbaum
Russian River PR