Regulatory Approvals

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...

Ophthalmic imaging company Heidelberg Engineering has secured US Food and Drug Administration (FDA) clearance for its ANTERION platform. ANTERION is an all-in-one upgradeable platform to transform...

Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent. A fully automated multi-analyte system,...

Masimo has received de novo approval from the US Food and Drug Administration (FDA) for ORi, its noninvasive, continuous parameter that delivers additional insight into a patient’s...

The US Food and Drug Administration (FDA) has cleared Establishment Labs’ tissue expander for breast reconstruction surgery. In a statement announcing the news, the US-headquartered company said...

As the wave of digitalisation sweeping across healthcare becomes more prevalent, the US Food and Drug Administration (FDA) has established a new advisory committee...

US-based histotripsy therapy firm has been given the green light by the US Food and Drug Administration (FDA) to bring its device that uses...