Envoy Medical Acclaim Implant Trial Hits Key Milestone
WHITE BEAR LAKE, Minn., April 22, 2026 Envoy Medical, Inc. announced a major milestone in its pivotal clinical trial...
FDA Breakthrough Device
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TOBY Gains FDA Breakthrough Status for MCED Test
AUSTIN, TEXAS, USA, April 14, 2026 TOBY, Inc. has received FDA Breakthrough Device Designation for its urine-based Multi-Cancer Early...
SafeHeal Launches Pivotal SAFE-3CV IDE Study for Colovac
Paris and Tampa, Fla., Jan. 13, 2026 — SafeHeal®, a clinical-stage medical device innovator in colorectal surgery, announced the...
FDA Grants Ceribell Breakthrough Status for LVO Stroke EEG
SUNNYVALE, Calif. | January 5, 2026 — Ceribell has received FDA Breakthrough Device Designation for its Large Vessel Occlusion...
Singlera–Pitt Advance Early Pancreatic Cancer Detection
LA JOLLA, Calif., Dec. 17, 2025 — Singlera Genomics announced a strategic research collaboration with the University of Pittsburgh...
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Bioretec Secures FDA Breakthrough Status for RemeOs™ DrillPin
TAMPERE, Finland — December 14, 2025 — Bioretec Ltd., a pioneer in fully biodegradable orthopedic implants, announced it has...
Envoy Advances Development of Fully Implanted Cochlear Implant with New Clinical Trial Milestone
WHITE BEAR LAKE, Minn., Dec. 10, 2025 — Envoy Medical announced the successful first set of activations in the...
Zimmer Biomet Earns FDA Breakthrough Status for Iodine-Treated Hip Implant
Warsaw, USA, October 28, 2025 — Zimmer Biomet Holdings, Inc. announced that the FDA has granted Breakthrough Device Designation...
BrainBox TBI Study Reveals Breakthrough in Concussion Diagnosis
RICHMOND, VA – October 17, 2025: BrainBox Solutions has published a major analysis in JAMA Network OPEN from its...
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