FDA regulators today announced that they granted premarket approval for NeuroPace for its anti-epilepsy device, an implantable neurostimulator that helps prevent seizures.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
State regulations are slowing health care innovation
(Diane Campbell Payne, used with permission)
By Naomi Fried
ReliantHeart expands CE Mark for HeartAssist5 ventricular assist device
ReliantHeart this week won expanded CE Mark approval in Europe for its ventricular assist device, which the company calls "the only remotely monitored VAD in the world."
The HeartAssist5 system originally won European approval under MicroMed Technology Inc. and was available commercially in 2009, according to a press release. ReliantHeart won the MicroMed’s assets through "the completion of a court approved transaction," the company said.
Report: Johnson & Johnson to settle DePuy ASR claims for $4B
Johnson & Johnson (NYSE:JNJ) is said to be close to settling the thousands of pending and future lawsuits involving its recalled DePuy ASR metal-on-metal hip implants, according to Bloomberg.
Anti-Essure movement grows online as women slam Bayer’s implant | MassDevice.com On Call
MASSDEVICE ON CALL — The anti-Essure movement, launched by women who claim the permanent contraceptive implant left them with severe pain and injuries, doesn’t look likely to die down, having spawned Facebook support pages, Twitter campaigns and lots of media attention.
The movement has attached itself to the Twitter hashtag ‘#EssureRally’, through which women are calling on Bayer to recall the device, posting pictures of the ralliers in action and organizing real-world events, including street-corner picketing and conference calls with famed consumer advocate Erin Brockovich.
Avedro wins CE Mark for its KXL II system
Waltham,Mass.-based Avedro said it won CE Mark clearance in the European Union for its KXL II cross-linking system.
The technology uses a photorefractive intrastromal cross-linking procedure for non-surgical correction of myopia as well to improve cataract surgery outcomes, according to a company statement.
Boston Scientific’s anti-stroke Watchman heart implant lands a date with the FDA
Boston Scientific (NYSE:BSX) won a date with an FDA advisory panel for its Watchman heart implant after the anti-stroke device met 2 of 3 endpoints in a clinical trial.
Cochlear Limited gets OK’d by FDA advisory panel
Cochlear Ltd. (ASX:COH) said an advisory committee to the FDA this week voted favorably on the Nucleus Hybrid L24 implant system, which combines acoustic amplification of low frequencies and electrical stimulation for high frequencies in a single device.
FDA: Baylis Medical recall is Class I
The FDA put a Class I label on Baylis Medical’s recall of its TorFlex transseptal guiding sheath kit, the federal watchdog agency announced.
The recall was issued because the sheath could remove particulate of less than 5mm from the dilator and the particulate could end up in the bloodstream, the FDA said.
FDA takes another look at ‘spinal spheres’ and stair-climbing wheelchairs
FDA regulators plan to meet next month to review a handful of medical devices and possibly recommend reclassification for spinal fusion ‘spheres’ and both stair-climbing and mechanical wheelchairs.
The agency noted in the Federal Register that its Orthopaedic & Rehabilitation Devices Panel will meet December 12 to review the technologies based on new reviews of their safety and effectiveness.
Germany’s BioCer lands E.U. win for mastectomy bra, U.S. win for hernia mesh
German medical device maker BioCer this week touted regulatory wins in the U.S. and in the U.K. for devices in its TiO2Mesh line, including for its mastectomy bra and hernia repair mesh.