Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...
Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20 (American Cancer Society, SEER estimates). Additional 2,600 primary bone cancer cases in young adults (20–39) ...
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SUNNYVALE, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with ...
ROCK HILL, S.C., Dec. 15, 2025 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced that the U.S. Food and Drug Administration has granted 510(k) clearance expanding the indications for its VSP ...
Enhanced wearable builds on Revi’s strong clinical evidence, meaningful symptom relief, and exceptionally high patient satisfaction. SALT LAKE CITY--(BUSINESS WIRE)--BlueWind Medical, Ltd., a leader ...
3D Systems (DDD) announced that the U.S. Food and Drug Administration has granted 510(k) clearance expanding the indications for its VSP Orthopedics virtual surgical planning and patient-specific ...
SAN MATEO, Calif.--(BUSINESS WIRE)--RapidAI, the global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D™ by RapidAI—an industry-first ...
The rapid molecular chlamydia and gonorrhea self-test provides results in 30 minutes from a self-collected swab sample, the firm said.
The US Food and Drug Administration cleared a number of molecular tests and immunoassays, as well as a clinical chemistry and a cellular deformation test.
BrainSpace announced that the FDA granted 510(k) clearance for its Intellidrop automated brain fluid management system.
Crescom Co. Ltd., an AI musculoskeletal imaging company, gained U.S. FDA 510(k) clearance Dec. 24 for MediAI-BA, its AI-powered pediatric and adolescent bone age analysis software. Classified as a ...
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