MedTech News
Gradient wins FDA breakthrough nod for pulmonary artery denervation tech
Gradient Denervation Technologies announced today that it received FDA breakthrough device designation for its denervation system.
FDA clears Trax Surgical Linkt nitinol compression staple system
Trax Surgical today announced it received FDA 510(k) clearance to market its Linkt Compression Staple System.
Aevice wins FDA nod for smart wearable stethoscope for pediatric patients
Aevice Health announced today that it received FDA 510(k) clearance for its AeviceMD smart wearable stethoscope device.
KNoW Biological Receives FDA Breakthrough Device Designation
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.
No more sticky patches: 3D-printed wearable monitors health through skin gases
Wearable technologies are revolutionizing health care, but design limitations in adhesive-based personal monitors have kept them from meeting their full potential
Wesper Revolutionizes Sleep Apnea Diagnosis with FDA-Cleared, Cannula-Free Technology
A patient-first solution redefines comfort and accuracy in sleep disorder testing across the U.S.
BiaCure Therapies Secures SBIR Phase I Grant to Advance Non-Invasive Fungal Nail Treatment
Innovative high-frequency energy technology aims to revolutionize onychomycosis care with a drug-free, patient-friendly solution.
Invisalign® Palatal Expander Gains Approval in China for Growing Patients
Align Technology’s non-invasive orthodontic innovation set to transform pediatric care in China.