MedTech News

Focused ultrasound with chemotherapy shows survival benefit for brain cancer patients, clinical trial finds
Patients with the deadliest form of brain cancer, glioblastoma, who received MRI-guided focused ultrasound with standard-of-care chemotherapy had a nearly 40% increase in overall survival in a landmark trial of 34 patients led by University of Maryland School of Medicine (UMSOM) researchers.

FDA greenlights Transmural Systems’ TAVR guidewire
Transmural Systems’ Telltale guide wire aims to prevent coronary obstruction by modifying the ‘leaflet’ tissue in high-risk patients undergoing TAVR.

CMS adds reimbursement for cardiac ablation in ASCs
The Centers for Medicare and Medicaid Services (CMS) has provided a major reimbursement update for cardiac ablation technologies.

CeriBell gets FDA nod for neonate seizure detection algorithm
CeriBell (Nasdaq:CBLL) announced today that it received FDA 510(k) clearance for its next-generation Clarity algorithm.

AI-driven system automates fax filing and digital consent, saving 8,500 staff hours
An emerging artificial intelligence-powered system developed at Penn Medicine has tripled the speed of fax processing and cut a full week off the new patient intake process—freeing up thousands of staff hours. The system, called coordn8, was created by the Penn Medicine Center for Health Care Transformation and Innovation (CHTI) and is detailed in a new paper published this week in NEJM Catalyst.

Regenity Biosciences Marks 63rd FDA 510(k) Clearance with Expansion of Neurosurgical Portfolio
PARAMUS, N.J., Nov. 25, 2025 /PRNewswire/ — Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced its 63rd FDA 510(k) clearance for DuraMatrix® Repair – Collagen Dura Regeneration Membrane, a resorbable membrane composed of highly purified Type I and Type III bovine collagen for the repair of dura mater defects during neurosurgery.

Nasal nanomedicine delivers immune-boosting therapy to fight brain tumors
Researchers at Washington University School of Medicine in St. Louis, along with collaborators at Northwestern University, have developed a noninvasive approach to treat one of the most aggressive and deadly brain cancers.

CMS approves coverage for Recor Medical renal denervation study
Recor Medical said today that it secured Medicare approval, granting coverage for the company’s RADIANCE CED study.