DUBLIN, April 16, 2025 /PRNewswire/ — LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, today announced the FDA clearance of its VERAFEYE™ Visualization Platform. This novel catheter-based imaging system provides real-time, two and four-dimensional, 360-degree visualization, significantly enhancing clinician precision and confidence during complex electrophysiology and structural heart procedures. The system is prepared for magnetic tracking and navigation of third-party catheters, which in the future, will further empower clinicians to perform complex procedures with greater precision and control.

PHILADELPHIA, April 15, 2025 /PRNewswire/ — ActiveProtective® (APT) is proud to announce the launch of Tango® Belt, a wearable medical device utilizing sensors to monitor motion and deploy airbags during serious hip-impacting falls. The Tango Belt, having already received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), was further granted marketing authorization as a prescription-only device intended as an adjunctive to standard-of-care to reduce the risk of hip fracture or hip dislocation due to falls in older adults at risk of major hip injury due to falls (DEN240021).

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.