MedTech News
Eversense® CGM System Receives iCGM Designation by the US FDA
The first fully implantable continuous glucose monitors can now be integrated with insulin pumps as part of an automated insulin delivery system
FDA clears Route 92 Medical’s FreeClimb 54 reperfusion system
Route 92 Medical today announced it received FDA 510(k) clearance for its FreeClimb 54 reperfusion system.
Axogen announces first surgical implant of Avive+ Soft Tissue Matrix
Axogen (Nasdaq:AXGN) this week announced the first surgical implantation of its Avive+ Soft Tissue Matrix.
Senseonics wins integrated CGM designation from FDA, can work with insulin pumps
The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS).
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott (NYSE: ABT)+
announced today that the FDA approved its Esprit everolimus-eluting resorbable scaffold system.
FDA clears new patient monitor from GE HealthCare
GE HealthCare (Nasdaq: GEHC)+
announced today that it received FDA 510(k) clearance for its Portrait VSM vital signs monitor.
ClearPoint Neuro wins FDA clearance for neuro laser therapy accessory
ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory.
Roivios Secures FDA Breakthrough Device Designation for JuxtaFlow® RAD, Showcases Pioneering Data at Society of Cardiovascular Anesthesiologists Annual Meeting
Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD).