Regulatory Approvals

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...

The StrivePD app uses Apple's Movement Disorder API to track tremors and uncontrolled body movement. Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use...

EarliTec Diagnostics, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood...

Zavation Medical announced that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part...