CapsoVision, a medical device company, submitted a 510(k) application to the FDA for an AI-assisted module designed for its CapsoCam Plus capsule endoscopy platform.  The tool aims to improve ...

StimLabs announces that the U.S. Food & Drug Administration (FDA) has granted 510 (k) clearance for Theracor, the first human umbilical cord-derived medical device to be offered in sheet form. This ...

Next-Generation Novasight Hybrid System Submitted to U.S. FDA for 510(k) Clearance U.S. and European Class 1A Guidelines Reinforce Growing Adoption of Image-Guided PCIPeer-Reviewed Publications Highli ...

Next-Generation Novasight Hybrid™ System Submitted to U.S. FDA for 510(k) Clearance U.S. and European Class 1A Guidelines Reinforce Growing ...

HeartSciences Inc. (Nasdaq: HSCS) ("HeartSciences" or the "Company"), a healthcare information technology ("HIT") company focused on advancing electrocardiography ...

Neosoma, a best-in-class provider of AI-based brain tumor analysis medical software, receives FDA 510(k) clearance for its Brain Mets product. This clearance ushers in a new era in the assessment of ...

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 ...

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.

Several ASX healthcare names secured US Food and Drug Administration approval in 2025, opening up the world's largest healthcare market.

The FDA has granted 510(k) clearance to a Bay Area medical technology firm for its proprietary delirium monitoring solution, ...

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