The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS).
Abbott (NYSE: ABT)+
announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system.
GE HealthCare (Nasdaq: GEHC)+
announced today that it received FDA 510(k) clearance for its Portrait VSM vital signs monitor.
ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.
Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD).
4WEB Medical this week announced it received regulatory clearance for its Anterior Spine Truss System with Anchor Fixation (ASTS-AF).
Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain
Inspira announced that it has received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device.
Groundbreaking technology for the precise, automatic measurement of peripheral blood vessels to optimize treatment strategies
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system.