MedTech News
FDA clears Onward’s ARC-EX System for home use in spinal cord injury care
Having been commercially available for less than 12 months, the system is now offered in over 60 US clinics.
Carea launches new Postpartum Mum Tracker
Carea, a pregnancy and postnatal wellbeing app that prioritises women’s health, has launched the Postpartum Mum Tracker to support the 1 in 5 new mothers who face post-birth mental health struggles.
Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology
PLANO, Texas, Nov. 18, 2025 /PRNewswire/ — Vesalio, a leader in innovative thrombectomy solutions, today announced two new FDA 510(k) clearances for its aspiration devices, designed for peripheral and neurovascular applications. These clearances mark a key milestone in Vesalio’s evolution toward providing a complete suite of thrombectomy products across multiple vascular territories.
Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections
CAMBRIDGE, Mass., Nov. 18, 2025 /PRNewswire/ — Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company’s novel assay for the rapid detection of infection in patients with suspected, or at risk of, complicated urinary tract infections (UTIs).
Piccolo Medical® Receives FDA Clearance to Expand ECGuide™ Technology Use to Pediatric and Neonatal Patients
SAN FRANCISCO, Nov. 18, 2025 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications for Use for its PM2™ System and ECGuide™ Connector. This clearance extends the technology’s use as an alternative to chest x-ray for a variety of central venous access devices in pediatric and neonatal patient populations.
Bot Image, Inc. Earns UKCA Certification for ProstatID® AI Prostate MRI Software Under EU MDR 2002 No. 618
OMAHA, Neb., Nov. 18, 2025 /PRNewswire/ — Bot Image, Inc., a leader in AI-powered diagnostic imaging, today announced that its flagship software, ProstatID®, has achieved UKCA certification under the European Union’s Medical Device Regulation (EU) 2017/745, marking yet another major milestone in the company’s global expansion.
AI tool mimics pathologists to improve breast cancer tissue analysis accuracy
A research team led by two University of Maine Ph.D. students developed an artificial intelligence (AI) system that could make it easier and faster for doctors to identify signs of breast cancer in tissue samples, possibly preventing delays and saving lives.
AI-assisted immune profiling helps predict treatment success in rectal cancer patients
Artificial intelligence (AI) can predict how well patients with rectal cancer will respond to treatment by analyzing standard tissue samples taken during diagnosis, finds a new study from researchers at UCL and UCLH.