Regulatory Approvals

Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, announced U.S. Food and Drug Administration (FDA) clearance of bolus insulin...

Amnio Technology, a global leader in the development of and distribution of amniotic tissue allografts is announcing the launch of two new PalinGen® membrane...

Though sustainability concerns usually make recyclable materials preferable to one-and-done options, when it comes to surgical devices, there’s an invaluable peace of mind and...

Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announces 510(k) clearance of the Equinoxe® Planning App (v. 2.0). The latest...

Chemence Medical, Inc., a manufacturer and distributor of adhesive-based medical devices, announced it received Food and Drug Administration clearance to market and sell the...

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, announced it has received...

“With clearance in hand for our guidance application, our near-term focus is getting the platform into the hands of surgeons as we work towards...

According to a press release, AtriAN Medicals clinical data from the Neural atrial fibrillation (AF) study was presented by Vivek Reddy (Mount Sinai Hospital,...

Sensydia, an innovator in rapid, non-invasive measurement of critical cardiac function, announced that its Cardiac Performance System (CPSTM) has been granted Breakthrough Device Designation by the United States...