Medical device makers face new obstacles to European approval
July 30, 2014 by Arezu Sarvestani
Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.
The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval. Read more
FDA panel narrowly OKs Cohera Medical's TissuGlu
August 1, 2014 by Brad Perriello
The FDA’s General & Plastic Surgery Devices Advisory Panel today narrowly recommended approval for Cohera Medical’s polyurethane-based TissuGlu adhesive for the approximation of tissue layers to bind subcutaneous dead space between the tissue planes in large flap surgical procedures, including abdominoplasty.
The panel voted unanimously that TissuGlu is safe; 6-5 that it is effective; and 6-4 with 1 abstention that the adhesive’s benefits outweigh its risks. Read more
FDA cuts fiscal 2015 user fees
July 30, 2014 by Brad Perriello
The FDA is cutting the user fees paid by medical device companies for the watchdog agency’s review by some 3% across the board for fiscal 2015.
The FDA’s Center for Devices & Radiological Health said today that it proposes to cut the fees for both small businesses making less that $100 million annually and for their larger brethren. Read more
Catching up with the FDA's 2014 guidance | MassDevice.com On Call
July 30, 2014 by Arezu Sarvestani
MASSDEVICE ON CALL — The FDA released a spate of new guidances in the 1st half of 2014, several with important implications for medical device and digital health companies.
Law360.com picked out some of the highlights from the year, including measures that affect how healthcare companies can communicate over social media and new rules that relax oversight of healthcare data systems and clinical decision software. Read more
FDA panel votes against Edap's ultrasound prostate cancer ablation
July 31, 2014 by Ingrid Mezo
The FDA’s Gastroenterology & Urology Devices panel yesterday voted against recommending approval of EDAP’s Ablatherm system for thermal ablation of the prostate gland to treat low-risk, localized prostate cancer.
The panel unanimously voted against Ablatherm’s effectiveness, in majority against the device’s safety (5 no votes, 3 yes votes and 1 abstention) and against its benefits outweighing its risks (8 no votes and 1 abstention). Read more