Regulatory Approvals

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...

TechMah CMF has received US Food and Drug Administration 510(k) clearance for its new medical device, the tmCMF Solution. The new device includes personalised product solutions for...

Allurion has completed patient enrolment in its pivotal trial designed to produce the necessary data for US Food and Drug Administration (FDA) approval of...

The US Food and Drug Administration (FDA) has cleared Sleepiz’s bedside device that monitors patients’ vital signs during sleep. The Sleepiz One+ device uses radar...