Tag:

FDA

Latest Headlines

Latest Headlines

Roche to sell Senseonics implantable glucose sensor system in some EU countries

Roche's Diabetes Care has signed a deal with implantable glucose sensor company Senseonics to sell its Eversense Continuous Glucose Monitoring System in Germany, Italy and the Netherlands. The deal comes just after a CE mark for the system earlier this month.

FDA approved high-risk women's health devices without proper data: Study

Some high-risk women's health devices were approved without proper data, according to a recent study. The findings point to a need for increased oversight from the agency, researchers said.

GERD neurostim startup nabs $25M to back ex-U.S. sales, conduct U.S. pivotal trial

Gastroesophageal reflux disease (GERD) is a common indication that's poorly served by existing drug therapies. Now Dutch startup EndoStim has gotten a $25 million Series D infusion to market its neurostimulation device to treat GERD outside the U.S. and to start a pivotal trial within it to gain FDA approval.

TransEnterix falls further as it ditches FDA-blocked surgical robot to focus on another

Investors are looking to place a bet on surgical robotics companies that can follow in the massive footprints of Intuitive Surgical. That company has long stood alone in the promising, but often treacherous field. Micro cap TransEnterix saw some of that Wall Street support earlier this year in advance of an expected clearance for the company's SurgiBot system.  

FDA rolls out draft guidance for 3-D printed medical devices

The FDA has unveiled new draft guidance for 3-D printing, laying out its thoughts on the technology and device regulation as more med tech companies jump into the fast-growing field.

FDA dubs recall for B. Braun hemodialysis system as Class I

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.

FDA approves a pair of Medtronic defibrillators to detect, treat atrial fibrillation

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 proposes Class I recall fix, 'on track' with Verily for next-gen glucose monitors

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.

FDA proposes ban on electrical shock devices for behavior modification

The FDA is concerned that electrical stimulation devices are being used for harm.

FDA snubs robotic surgery player TransEnterix, shares off by more than half

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.