Regulatory Approvals

Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. Food and Drug Administration (FDA) has...

Stereotaxis has announced the CE Mark submission for its MAGiC™ catheter. The MAGiC catheter is a robotically navigated magnetic interventional ablation catheter for minimally invasive...

The trial will assess the use of the Genio system to treat moderate to severe OSA and CCC in adult patients. Medical technology firm Nyxoah...

Renovia Inc. ("Renovia"), a developer of non-surgical, treatments for female pelvic floor disorders and an advocate for women's health, announced that the U.S....

Ra Medical Systems, Inc. (NYSE American: RMED)(“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system to treat...

It has been approved as a prescription-only software-as-a-medical device in the US. ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance...

LiveOne combines MEMS nanosensors with AI algorithms to provide BP measurement. LiveMetric has received 510(k) clearance from the US Food and Drug Administration (FDA) for LiveOne, a...

Radiobotics’ RBfracture has been CE-marked under MDR (European Medical Device Regulations) as a class IIa medical device, positioning the Danish healthtech company among some of the first...

MolecuLight i:X allows visualisation of regions containing bacterial species at the point-of-care. The US Food and Drug Administration (FDA) has granted expanded 510(K) clearance for MolecuLight’s i:X...