
AorticLab earns expanded CE mark for embolic protection device
AorticLab announced today that its FLOWer device received CE mark approval for extended use in transcatheter cardiovascular procedures.

AorticLab announced today that its FLOWer device received CE mark approval for extended use in transcatheter cardiovascular procedures.

LEM Surgical announced today that the FDA granted a new 510(k) clearance for its Dynamis robotic surgical system.

Masimo, a Danaher (NYSE:DHR) company, today announced FDA clearance for an opioid-induced respiratory depression (OIRD) detection platform.

FiberSense has announced that its Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017/745 as a Class IIb medical device. The system is intended for continuous monitoring of blood sugar levels and glucose trends in adults with diabetes.

AngioDynamics (Nasdaq:ANGO) announced today that it received FDA investigational device exemption (IDE) to initiate the RELIEF study.

The AMDI™ Mini Respiratory Panel delivers RT-PCR results in under 10 minutes, enabling clinical action in the Time of Care™

Oculogica announced earlier this month that it won FDA 510(k) clearance for the SNAP concussion test.

Distalmotion announced today that it received FDA 510(k) clearance for its Dexter surgical robot in a range of gynecology procedures.

Dexcom (Nadsaq:DXCM) has received FDA clearance for its Stelo over-the-counter (OTC) continuous glucose monitor (CGM) for children.

SurGenTec announced today that the FDA cleared its ION-L lumbar facet fixation system for degenerative disc disease (DDD).