Food & Drug Administration (FDA)
Medtronic’s guidewire recall gets FDA’s highest-risk label | MassDevice.com On Call
MASSDEVICE ON CALL — Medical device titan Medtronic (NYSE:MDT) announced late last week that the FDA had put its highest-risk label on a company recall of certain guidewires. The agency deemed the recall a "Class I" issue, reserved for device defects that could "cause serious adverse health consequences or death."
Lumenis wins U.S. & Japanese clearance for retinal laser treatment
Lumenis Ltd. announced today regulatory wins in the U.S. and Japan for its Array LaserLink pattern scanning device for multi-spot laser photocoagulation for use during retinal surgery.
The Array LaserLink, which turns an "examination slit lamp" into a medical laser, expands on the Lumenis laser system to deliver “pattern scanning capabilities, aimed to provide greater predictability in retinal treatments and presumably less collateral damage to the retina,” according to a press release.
FDA lowers regulatory oversight of scleral plugs for eye surgery
The FDA this week issued its final rule on scleral plugs, down-classifying them to a lower-risk category of medical devices in need of less stringent review.
FLASH: FDA approves NeuroPace’s anti-epilepsy implant
FDA regulators today announced that they granted premarket approval for NeuroPace for its anti-epilepsy device, an implantable neurostimulator that helps prevent seizures.
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.
FDA report puts spotlight back on Intuitive Surgical’s adverse events spike
Topera lands CE Mark, 510(k) clearance for heart catheter
Topera said it landed a pair of regulatory wins for its FIRMap catheter.
The Palo Alto, Calif.-based medical device company said it won the CE Mark approval in the European Union and 510(k) clearance from the FDA for the device.