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Germany -
German court rejects compensation claim over faulty breast implants

Germany's federal supreme court said on Thursday it had rejected a woman's claim for certification agency TÜV Rheinland to pay compensation for approving faulty breast implants produced by manufacturer PIP until its 2010 closure. Poly Implant Prothèse (PIP), the French company at the center of the scandal, sold implants globally over almost two decades until investigators discovered it was passing off low-grade industrial silicone as a much pricier medical product. The counterfeit substance was used in implants given to some 300,000 women. About one-quarter of those subsequently removed were...

Worldwide -
Will Theranos Settle Walgreens Feud for Less Than $30M?

The embattled startup continues to chip away at heaps of litigation while focusing its business efforts on developing and selling a tabletop blood-testing device. Theranos promised to "vigorously" defend itself against Walgreens , and it appears the embattled blood testing company and its lawyers have done a surprisingly decent job of it. The Wall Street Journal ( WSJ ) reported Wednesday that Theranos and Walgreens reached a tentative settlement in which Theranos would pay the drugstore company less than $30 million. That’s a pretty good deal for Theranos, considering Walgreens had...

International -
5 secrets of contract manufacturing longevity

Whether it’s a few decades or the better part of a century, there are important factors that enable a contract manufacturer to last for a long time – business traits that OEM customers should value. We asked top executives from long-lasting medical device industry suppliers to share their secrets...

UK -
Guidance: Notified bodies for medical devices

This Medicines and Healthcare products Regulatory Agency (MHRA) guidance covers: the legislation which governs medical devices the role of the notified body lists of approved notified bodies how to become a notified body Notified bodies for medical devices Requirements for UK notified bodies

France -
CNEDiMTS : Appel à candidature

Appel à candidature pour la Commission Nationale d'Evaluation des Dispositifs Médicaux et des Technologies de Santé (CNEDiMTS) – Mandat 2015/2018 – ouvert jusqu’au 15 juillet 2017.

France -
Quand la CNEDiMTS retarde l’accès à l’innovation

C’est l’histoire d’une demande de prise en charge relative à un dispositif implantable innovant dénommé UROLIFT® qui, malgré son intérêt pour une catégorie bien identifiée de patients et des données cliniques probantes de haut niveau de preuve, a dû être examinée deux fois par la CNEDiMTS, à 18 mois d’intervalle, pour obtenir un avis laissant espérer que des patients en mal de solution thérapeutique satisfaisante pourront enfin en bénéficier. La pose d’implants intra-prostatiques UROLIFT ® se traduit par la compression mécanique des deux lobes prostatiques latéraux par voie endoscopique...

International -
Wearable Aims to Improve Management of Parkinson’s Disease

The Personal KinetiGraph System from Global Kinetics Corporation offers objective measurement and analysis of patient movement, allowing clinicians to better assess and treat the disease. Global Kinetics Corporation may be a digital health company, but it doesn’t offer the typical wearable device. The Melbourne, Australia-based company has developed the Parkinson’s KinetiGraph (PKG) System—known as the Personal KinetiGraph in the United States—for patients with Parkinson’s disease. The technology includes the PKG-Watch, a wrist-worn data logger that is used to monitor patient movement, and...

International -
How Device Makers Can Combat Rising Healthcare Costs and Prep for Policy Changes

A new report from PwC highlights the factors behind ever-higher healthcare spending. Here’s how the medical device industry can help deflate care costs and prepare for potential new policies. Here’s the good news: We aren’t likely to see skyrocketing medical costs next year. But the growth in medical costs isn’t slowing markedly either. In the “Medical Cost Trend: Behind the Numbers 2018” annual report, the experts at PwC’s Health Research Institute (HRI) forecast a 6.5% growth rate for medical costs in 2018. That’s in line with the 6-7% growth that has been observed for the last four years,...

Discovery -
Researchers develop new test to target prostate cancer treatment

UK-based scientists have developed a new three-in-one blood test able to identify the patients with advanced prostate cancer most likely to benefit from PARP inhibitors, with the potential to ‘transform’ treatment of the disease. By testing cancer DNA in the bloodstream, researchers from The Institute of Cancer Research (ICR), London, and The Royal Marsden NHS Foundation Trust, were also able to pick out patients not responding to treatment so that they could be switched to alternative therapy in just four to eight weeks...

USA -
FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review. The pilot, part of a new approach to regulating digital health tools, would help to certify, according to Gottlieb, whether a company "consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its...

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