Regulatory Approvals

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...

LungFit PH uses ambient air to generate unlimited, on-demand nitric oxide to treat hypoxic respiratory failure in neonates. The US Food and Drug Administration (FDA)...

Innovative Transseptal Access System Is First and Only to Feature Integrated Dilator and Needle to Reduce Exchanges Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia...

Envoy Medical® Corporation, a hearing health company focused on providing innovative technologies across the hearing loss spectrum, announced the U.S. Food and Drug Administration...

Carthera announced that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin....

The company has also launched a distribution unit in the United States. Auckland-based health technology startup Alimetry has received clearance from the US Food and...

Senseonics announced that it received CE mark for the next-generation Eversense E3 CGM system. Germantown, Maryland-based Senseonics offered a previous-generation continuous glucose monitor (CGM) with a...

Ekso Bionics (Nasdaq:EKSO) announced that it received FDA 510(k) clearance for its EksoNR robotic exoskeleton. Richmond, California–based Ekso Bionics designed the EksoNR technology for use with...