MyKidneyAI Becomes the Company’s Second Innovation to Recently Receive this FDA Distinction
The first fully implantable continuous glucose monitors can now be integrated with insulin pumps as part of an automated insulin delivery system
Route 92 Medical today announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system.
Axogen (Nasdaq:AXGN) this week announced the first surgical implantation of its Avive+ Soft Tissue Matrix.
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).