Regulatory Approvals

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Neurovalens’s Modius Sleep, a device used to treat chronic insomnia. The Belfast-based company...

Creo Medical’s Speedboat UltraSlim to hit the market in early 2024 following guidance from EU regulator. UK-based company Creo Medical is planning the launch of...

Chordate Medical has obtained the registration of the trademark Ozilia® in the EU from EUIPO (EU Intellectual Property Office) in trademark classes 9 and...

Recor Medical has followed up its US Food and Drug Administration (FDA) approval of its Paradise ultrasound renal denervation system earlier this year with...

The US Food and Drug Administration (FDA) has approved MTF Biologics’s trial using the FlexHD Pliable device in breast reconstruction after the agency granted...

DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™...

AACHEN, Germany--(BUSINESS WIRE)--Protembis GmbH (Protembis) a privately-held emerging cardiovascular medical device company, announced today the FDA has approved the PROTEMBO Pivotal IDE Trial (NCT05873816)....

Cardio Flow has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its FreedomFlow Orbital Atherectomy Peripheral Platform. The platform deploys a...

Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the EndoCore EBUS-TBNA fine needle biopsy device. Endobronchial ultrasound with...