
CeriBell earns FDA nod for pediatric seizure detection software
CeriBell (Nasdaq:CBLL) announced today that it received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm.

CeriBell (Nasdaq:CBLL) announced today that it received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm.

EBR Systems announced that it received FDA approval for its wireless cardiac pacing device for heart failure

DESKi today announced FDA clearance of HeartFocus, its AI-enabled heart exam software.

First Dual-Layer Micromesh Carotid Stent Approved for Use in the U.S.

Dexcom (Nasdaq: DXCM) today announced a significant regulatory milestone for its continuous glucose monitoring (CGM) technology.

Intuitive (Nasdaq: ISRG) announced today that it received FDA clearance for its fully wristed SP SureForm 45 stapler.

Zeiss Medical Technology announced today that it received FDA 510(k) clearance for the Intrabeam 700 platform.

New Approval Expands Use of Porous Biologic Scaffold for Intervertebral Disc Space Fusion Procedures

HighLife announced that it received FDA breakthrough device designation for its trans-septal mitral valve replacement (TMVR) solution.

Brainomix announced today that it received FDA clearance for a new feature within its 360 Stroke solution for AI-powered stroke imaging.