SAN FRANCISCO, Feb. 25, 2025 /PRNewswire/ — Averto Medical, a clinical-stage medical device company pioneering minimally invasive gastrointestinal care, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its ColoSeal™ Intraluminal Colonic Diversion (ICD) System. This designation underscores the potential of ColoSeal™ to significantly improve outcomes for patients undergoing colorectal surgery by eliminating the need for a temporary ostomy.

Tandem Diabetes Care (Nasdaq:TNDM) today announced a major regulatory win that brings its diabetes technology to more patients.

SANTA BARBARA, Calif., Feb. 24, 2025 /PRNewswire/ — Aptitude Medical Systems, Inc. (Aptitude) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its next-gen molecular Metrix® COVID/Flu multiplex test. This innovative test represents a major advancement in accessible molecular diagnostics.

DUBLIN, Ohio, Feb. 20, 2025 /PRNewswire/ — Atreon Orthopedics, LLC, a Columbus based innovator in tissue healing and regenerative technologies, announces the 510(k) clearance from the Food and Drug Administration (FDA) and the full market launch of BioCharge® Autobiologic Matrix, a bioresorbable synthetic implant designed to address biological failure modes in rotator cuff repair while improving repair integrity and long-term patient outcomes.

MELBOURNE, Australia, Feb. 16, 2025 /PRNewswire/ — Navi Medical Technologies, a medical device company focused on pediatric healthcare innovation, proudly announces that its Neonav® ECG Tip Location System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

With FDA clearance of SubtleHD™, Subtle Medical launches Subtle-ELITE™, an industry-first AI package designed to achieve superior image quality, unprecedented speed, and workflow automation