An FDA panel today voted today to recommend approval for Staar Surgical’s (NSDQ:STAA) novel Visian Toric implantable collamer lens for treatment of myopic astigmatism in adults aged 21-45.
FDA panel recommends highest-risk group for spinal spheres
The FDA’s Orthopedic & Rehabilitation Devices advisory panel last week recommended that the watchdog agency classify spinal sphere devices into its highest risk Class III category because there is insufficient evidence of their safety and effectiveness when used in intervertebral body fusion procedures.
UPDATE: FDA panel OKs Boston Scientific’s Watchman anti-stroke implant
The FDA’s Circulatory Systems Devices Panel voted 13-1 yesterday to recommend approval of Boston Scientific‘s (NYSE:BSX) Watchman heart implant for reducing the risk of stroke and systemic embolism.
Boston Scientific’s Watchman anti-stroke implant wins over FDA panel
The FDA’s Circulatory Systems Devices Panel today voted 13-1 to recommend approval of Boston Scientific’s(NYSE:BSX) Watchman 1st-of-its-kind left atrial appendage (LAA) closure device for reducing the risk of stroke and systemic embolism.
UPDATE: FDA panel issues mixed vote on CardioMEMS Champion device
Updated October 10, 2013, at 5 p.m. with comments from the CDRH panel.
UPDATE: FDA panel hands Medtronic a narrow win
FLASH: FDA panel narrowly recommends expanding indication for Medtronic pacemakers
UPDATE: FDA panel approves Ocular Therapeutix’ ReSeal, with reservations
An FDA advisory panel voted yesterday that Ocular Therapeutix’s ReSure topical hydrogel post-op sealant is safe, but split on questions of efficacy and whether the benefits of the treatment outweigh its risks.
The FDA’s Ophthalmic Devices Panel voted 9-1, with 1 abstention, that the ReSure sealant is safe; 5-3, with 3 abstentions, that it is effective; and 5-1, with 5 abstentions, that its benefits outweigh its risks.
FDA eye experts give mixed recommendation for post-op sealant
A panel of experts today voted that Ocular Therapeutix’s ReSure Sealant topical hydrogel post-op sealant is safe, but panelists were split on questions of efficacy and whether the benefits of the treatment outweigh the risks.
Neurotech firms Jan Medical, Brainlab team up
Jan Medical is partnering with software-driven medtech firm Brainlab to gain FDA clearances via 2 clinical trials, the companies announced.
As part of the collaboration, Brainlab will add a representative to Jan Medical’s board, the companies said in a press release.
Mountain View, Calif.-based Jan Medical makes the the Nautilus NeuroWave, a portable, non-invasive brain sensing system designed to detect abnormal neurological conditions, including ischemic stroke, vasospasm, and concussion.
Study: Remotely monitored heart patients live longer
Heart failure patients with implant-based remote monitoring die less frequently from any cause, according to Biotronik study results released at the European Society of Cardiology congress in Amsterdam.