UPDATED Oct. 22, 2015, with details on additional legislation. Indiana’s junior senator, Sen. Joe Donnelly (D-Ind.), yesterday launched a “medical innovation agenda” by co-sponsoring a pair of bills and signing on to 3 others that aim to streamline the FDA’s approval process. Donnelly and Sen. Cory Gardner (R-Colo.) co-sponsored a pair of new bills, the Rare Device Innovation Act and […]
Food & Drug Administration (FDA)
Exit interview: Stephen Ubl on moving on from AdvaMed
Before Stephen Ubl departed for a job as the chief lobbyist for the pharmaceutical industry, medtech’s main man in Washington, D.C., sat down with MassDevice.com publisher Brian Johnson to reflect on his time at AdvaMed. Ubl worked 16 years at the Advanced Medical Technology Assn., spending the last 10 years as president & CEO, raising the medical device industry’s national […]
FDA CDRH issues 2016 regulatory science priorities
The FDA’s Center for Devices and Radiological Health this week released its regulatory science priorities for fiscal year 2016, picking out 10 areas of focus. The priorities will serve to improve safety, effectiveness, performance and quality of medical devices and radiation-emitting products, according to the agency, as well as facilitating the introduction of new devices […]
Osprey Medical dives on failed trial despite FDA wins
Australian investors, reacting today to news that Osprey Medical (ASX:OSP) failed to meet a key endpoint in a clinical trial, took OSP shares down by some -55% today. The plunge came despite news that the FDA approved expanded claims for Osprey’s Avert device, which is designed to reduce and monitor the amount of contrast agent injected […]
FDA approves expanded trial for InVivo Therapeutics spinal cord treatment
InVivo Therapeutics (OTC:NVIV) said today that it won a nod from the FDA to double the enrollment in a clinical trial of its neuro-spinal scaffold. Cambridge, Mass.-based InVivo enrolled the 5th patient in the pilot study last month. Its bioabsorbable device is designed to treat acute spinal cord injuries. “I am very pleased to have come to such […]
Orfit wins CE Mark, FDA 510(k) for immobilization system
Orfit said today it won FDA 510(k) clearance and CE Mark approval in the European Union for its HP Pro Solution immobilization system for use during proton therapy treatments. The system is designed for use during proton therapy procedures for the brain, head and neck, and can be used with Orfit’s Nanor immobilization masks. “Ensuring […]
FDA warns on infections from surgical heater-coolers
The FDA issued a warning over issues with infections associated with heater-cooler devices during cardiothoracic and other surgical procedures. Heater-cooler devices use water tanks to provide temperature-controlled water to keep patients warm or cool during surgical procedures. While water in the devices does not contact patients, the federal watchdog warned that there is potential that contaminated […]
FDA clears SonaCare HIFU prostate device, prompts Edap to yank de novo, go for 510k
SonaCare said it won FDA pre market approval for its high intensity focused ultrasound device designed to treat prostate cancer, causing competitor EDAP (NSDQ:EDAP) to yank the de novo application for its Ablatherm HIFU. SonaCare said its Sonablate 450 will be available in the U.S. this October. “The FDA regulatory authorization to market Sonablate in the […]
New FDA guidance for medical devices using animal studies
By Stewart Eisenhart, Emergo Group The FDA has published a new draft guidance covering design and reporting processes for animal studies conducted for medical devices. US FDA guidance on animal studies for medical devicesIntended for both industry and the agency’s own reviewers, the guidance pertains to animal studies submitted as part of Investigational Device Exemption (IDE) investigation applications, […]
Baxter wins FDA nod for Amia dialysis device
Baxter (NYSE:BAX) said yesterday that it won 510(k) clearance from the FDA for its Amia automated peritoneal dialysis system, saying it plans to launch the device in the U.S. this year. The Amia device, which uses Deerfield Park, Ill.-based Baxter’s ShareSource web-based remote connection, is designed for home use by patients with end-stage renal disease. Baxter claimed […]
Study finds higher surgery risk with Bayer’s Essure
(Reuters) — Women implanted with Bayer‘s (ETR:BAYN) Essure female sterilization device were more than 10 times more likely to require post-procedure surgery than those who underwent laparoscopic sterilization, according to a study published today in the British Medical Journal. The findings could cast additional doubt on the safety of the Bayer device, which was approved in 2002 as […]