FDA greenlights Transmural Systems’ TAVR guidewire
November 24, 2025
Transmural Systems’ Telltale guide wire aims to prevent coronary obstruction by modifying the ‘leaflet’ tissue in high-risk patients undergoing TAVR.
Transmural Systems’ Telltale guide wire aims to prevent coronary obstruction by modifying the ‘leaflet’ tissue in high-risk patients undergoing TAVR.
The Centers for Medicare and Medicaid Services (CMS) has provided a major reimbursement update for cardiac ablation technologies.
CeriBell (Nasdaq:CBLL) announced today that it received FDA 510(k) clearance for its next-generation Clarity algorithm.
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.
Recor Medical said today that it secured Medicare approval, granting coverage for the company’s RADIANCE CED study.
Overture’s DaVitri system aims to make egg thawing and freezing processes during IVF more consistent to improve successful embryo formation outcomes.
QuantalX’s Delphi-MD is applicable for the diagnosis, monitoring, and treatment evaluation of a range of neurological conditions.
Paradromics announced today that it received FDA investigational device exemption (IDE) to begin a study of its brain-computer interface (BCI).
EDAP TMS SA (Nasdaq:EDAP) announced today that the FDA granted 510(k) clearance for new workflows for its ultrasound technology.
Dexcom (NSDQ:DXCM) announced today that the FDA cleared its Smart Basal CGM-integrated basal insulin dosing optimizer.