Gradient wins FDA breakthrough nod for pulmonary artery denervation tech
May 19, 2025
Gradient Denervation Technologies announced today that it received FDA breakthrough device designation for its denervation system.
Gradient Denervation Technologies announced today that it received FDA breakthrough device designation for its denervation system.
Trax Surgical today announced it received FDA 510(k) clearance to market its Linkt Compression Staple 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.
Wearable technologies are revolutionizing health care, but design limitations in adhesive-based personal monitors have kept them from meeting their full potential
A patient-first solution redefines comfort and accuracy in sleep disorder testing across the U.S.
Innovative high-frequency energy technology aims to revolutionize onychomycosis care with a drug-free, patient-friendly solution.
Align Technology’s non-invasive orthodontic innovation set to transform pediatric care in China.
Virtuoso Surgical CEO Duke Herrell took to LinkedIn to announce successful first-in-human clinical cases with the company’s robotic endoscopy system.
Autonomix Medical (Nasdaq:AMIX) announced that it received a new patent titled controlled sympathectomy and micro-ablation systems and methods.