B. Braun Medical has recalled a hemodialysis system to treat chronic kidney disease patients that could allow air to enter the dialysis solution. This could lead to improper blood filtration as well as other consequences including death--so the FDA has now given the recall its most serious designation of Class I.
Atrial fibrillation can be difficult to diagnose, but patients with untreated AF are 5 times more likely to have a stroke and three times more likely to develop heart failure. Now, the FDA has approved a pair of implantable cardioverter defibrillators from Medtronic specifically for previously undiagnosed and/or asymptomatic AF patients, as well the monitoring and treatment of recurrent AF.
Dexcom is working to refocus in the wake of a recent Class I recall for its speakers that applied across several models of its continuous glucose monitors (CGM). The company has submitted a filing for a replacement speaker and related manufacturing changes with the FDA, it said on an April 27 earnings call.
The FDA is concerned that electrical stimulation devices are being used for harm.
The FDA has rejected the 510(k) application for a surgical robot from small-cap TransEnterix. In response, its shares fell almost 60% in early trading--pushing its market cap down to almost $200 million. The company had been a market darling earlier this year in anticipation of the FDA decision--and on anticipation of more real competitors challenging dominant Intuitive Surgical in robotic surgery.
Cartiva got a go-ahead in the path toward a potential PMA approval for its Synthetic Cartilage Implant (SCI) to treat osteoarthritis at the base of the great toe. The FDA's Orthopaedic and Rehabilitation Devices Panel voted in support of Cartiva SCI efficacy, safety and that its benefits outweigh its risks. The SCI implant could offer an alternative to a joint fusion approach.
Superbug outbreaks tied to duodenoscope devices have caused regulators to step up their oversight of the products. But one lawmaker wants the agency to go even further and is asking Congress to back his efforts.
More than 5,000 hemostasis valves have been recalled by Vascular Solutions under a recall that's been deemed Class I by the FDA. That classification means the recalled device is a serious health risk or potentially could cause death.
It's been more than 10 years since the FDA signed off on Merck KGaA's fertility drug Luveris. But now, after the company failed to conduct a postmarketing trial, the FDA has yanked the drug's approval at the German pharma's request.
A crackdown by the FDA on Indian drugmakers that have slipshod manufacturing standards has already taken a toll on India's pharma industry. But now, the FDA actions are having ramifications beyond the U.S. market.