MedTech News
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.
Virtuoso Surgical reports first cases with robotic endoscopy system, plans FDA IDE submission
Virtuoso Surgical CEO Duke Herrell took to LinkedIn to announce successful first-in-human clinical cases with the company’s robotic endoscopy system.
Autonomix picks up key nerve ablation catheter patent
Autonomix Medical (Nasdaq:AMIX) announced that it received a new patent titled controlled sympathectomy and micro-ablation systems and methods.
Intalight™ Receives CE Mark for Its Progressive DREAM OCT™ Swept Source Imaging
SAN JOSE, Calif. and SHANGHAI, May 15, 2025 /PRNewswire/ — Intalight™, a company that develops advanced ophthalmic technologies and a leader in Optical Coherence Tomography (OCT) today announced it has received CE mark for its DREAM OCT™ platform.