The FDA updated its list of breakthrough devices as medtech groups lobby for faster Medicare coverage of products with the designation.

Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.

The minimally invasive system uses radiofrequency energy to target nerve tissue causing facial pain.

The startup intends to make a small patch pump with a closed-loop algorithm for nighttime glucose control.

The FDA said the request to quarantine the devices followed reports of the products “resisting shape retention when being ...

O’Hara joins CMR’s executive team as commercial president and general manager for the U.S., following the FDA’s authorization ...

CEO Geoff Martha told investors that the initiatives were done in partnership with the activist investor firm Elliott ...

The update covers devices used in procedures to implant the company’s Watchman heart device.

The fresh funding will support pivotal trials in progress and commercialization preparations at the two heart-focused ...

New limits to the program could force hospitals to slash capital spending while bracing for millions of newly uninsured ...

July and August have brought a steady beat of private financings for young medtech companies, with several deals supporting ...

The company said it has grown capacity by 10% this year, bringing its total U.S. output of the prefilled flush syringes to ...