MedTech News
Alafair Biosciences Receives 510(k) Clearance for VersaCoat™ Tendon Protector and VersaCoat™ Nerve Protector
AUSTIN, Texas, July 30, 2025 /PRNewswire/ — Alafair Biosciences, a medical device company redefining soft-tissue protection in orthopedic surgery, announced today that it has received two 510(k) clearances from the FDA for VersaCoat™ Tendon Protector and VersaCoat™ Nerve Protector, marketed as a single product, VersaCoat™ Flowable Hydrogel.
Bioventus wins FDA nod for duo of next-gen peripheral nerve stim products
Bioventus (Nasdaq:BVS) announced today that it received FDA 510(k) clearance for both its TalisMann and StimTrial offerings.
Smart wound monitor poised to improve chronic infection care
Researchers from RMIT University have developed a wearable wound monitoring device with integrated sensors that could reduce infection risks by minimizing the need for frequent physical contact. Their study, “Multiplexed cutaneous wound monitor for point-of-care applications,” was published in Advanced NanoBiomed Research.
Wearable device uses ambient light for 24-hour health monitoring
Miniaturization and weight reduction of medical wearable devices for continuous health monitoring such as heart rate, blood oxygen saturation, and sweat component analysis remain major challenges.
Using AI and wearable sensors to detect inflammation before symptoms appear
Modern medicine is largely reactive—treating illness only after symptoms emerge. But a new study from the Research Institute of the McGill University Health Center (The Institute) and McGill University points to a more proactive future: one where silent signs of infection are detected before we even feel sick.
Progress in gene therapy offers hope for long-term knee pain relief
For nearly three decades, Mayo Clinic researcher Christopher Evans, Ph.D., has pushed to expand gene therapy beyond its original scope of fixing rare, single-gene defects. That has meant systematically advancing the field through laboratory experiments, pre-clinical studies and clinical trials.
BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
FRANKLIN LAKES, N.J., July 30, 2025 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Veritor™ System for SARS-CoV-2, a digital test designed to detect COVID-19 antigens in symptomatic individuals in about 15 minutes at doctors’ offices, urgent care centers, retail clinics and other convenient points of care.
Gnosis Launches EdenDx, the First Non-Invasive Liquid-Based Cytology U.S. Test for Early Endometrial Cancer Detection
ORANGE, Calif., July 30, 2025 /PRNewswire/ — Gnosis, a Southern California-based diagnostic lab advancing women’s health through molecular innovation, today announced the national launch of EdenDx, which stands for Early Detection for Endometrial Neoplasia, the first commercially available non-invasive liquid-based cytology test in the United States for early-stage endometrial cancer detection.