Subtle Medical Gains FDA Clearance for SubtleHD PET
MENLO PARK, Calif., May 27, 2026 Subtle Medical, a leading developer of AI-powered medical imaging software, has announced that...
FDA Breakthrough Device
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TOBY Gains FDA Breakthrough Status for Alzheimer’s Test
AUSTIN, Texas, May 26, 2026 TOBY, Inc., a biotechnology company focused on non-invasive disease detection technologies, has announced that...
Cepheid Gains IVDR CE Mark for Xpert GI Panel
SUNNYVALE, Calif., May 13, 2026 Cepheid, a Danaher company, announced that it has received CE marking under the European...
Pfizer Wins EU Approval for HYMPAVZI in Hemophilia
NEW YORK, May 13, 2026 Pfizer has received European Commission approval for HYMPAVZI® (marstacimab) for the treatment of adults...
Exero Medical Highlights FDA Breakthrough xBar Study at ASCRS 2026
JERSEY CITY, N.J. and OR YEHUDA, Israel, May 11, 2026 Exero Medical has announced positive pivotal clinical study results...
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PreludeDx Secures FDA Breakthrough for AidaBREAST Test
LAGUNA HILLS, CALIFORNIA, April 29, 2026 PreludeDx has announced that the U.S. Food and Drug Administration (FDA) has granted...
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...
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...
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