FDA Clears Argos Infinity for Advanced Cardiac Monitoring
WHITE PLAINS, NEW YORK, UNITED STATES — February 16, 2026 Retia Medical has received U.S. FDA 510(k) clearance for...
medical device regulation
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STIMULAN Gains MDR Certification for Infection Care
KEELE, United Kingdom, Feb. 5, 2026 — Biocomposites announced that its STIMULAN® Rapid Cure and STIMULAN® Kit have received...
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...
FDA Clears StimLabs’ Theracor, First Umbilical Cord Sheet
ROSWELL, Ga., December 29, 2025 — StimLabs has announced that the U.S. Food and Drug Administration (FDA) has granted...
FDA Review Begins for Motiva Implants in Breast Reconstruction
SAN JOSÉ, Costa Rica, Dec. 29, 2025 — Establishment Labs has submitted a regulatory application to the U.S. Food...
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