FDA Breakthrough Device

AUSTIN, TEXAS, USA, April 14, 2026 TOBY, Inc. has received FDA Breakthrough Device Designation for its urine-based Multi-Cancer Early...

Paris and Tampa, Fla., Jan. 13, 2026 — SafeHeal®, a clinical-stage medical device innovator in colorectal surgery, announced the...

SUNNYVALE, Calif. | January 5, 2026 — Ceribell has received FDA Breakthrough Device Designation for its Large Vessel Occlusion...

LA JOLLA, Calif., Dec. 17, 2025 — Singlera Genomics announced a strategic research collaboration with the University of Pittsburgh...

TAMPERE, Finland — December 14, 2025 — Bioretec Ltd., a pioneer in fully biodegradable orthopedic implants, announced it has...

WHITE BEAR LAKE, Minn., Dec. 10, 2025 — Envoy Medical announced the successful first set of activations in the...

Warsaw, USA, October 28, 2025 — Zimmer Biomet Holdings, Inc. announced that the FDA has granted Breakthrough Device Designation...

RICHMOND, VA – October 17, 2025: BrainBox Solutions has published a major analysis in JAMA Network OPEN from its...