Route 92 Medical announced today that it received FDA 510(k) clearance for its HiPoint reperfusion system.

New basivertebral nerve ablation device aims to relieve chronic vertebrogenic low back pain

Gradient Denervation Technologies announced today that it received FDA breakthrough device designation for its denervation system.

Aevice Health announced today that it received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope device.

ATLANTA, May 13, 2025 /PRNewswire/ — KNoW Biological has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). This designation is an FDA program designed to expedite the review of devices and medications for serious or life-threatening conditions where there’s preliminary evidence suggesting substantial improvement over existing therapies on the market.

A patient-first solution redefines comfort and accuracy in sleep disorder testing across the U.S.