The assay is the first to receive FDA 510(k) clearance and CLIA waiver for use with Diasorin's Liaison Nes platform.

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, ...

Following the expanded FDA indication, case-by-case compassionate-use approvals and hospital IRB reviews previously required ...

The KPAP sleep therapy platform is developed to offer an adaptive and patient-focused alternative to traditional CPAP therapy ...

The market for AI in medical devices is booming. Analysts are putting the value in the billions, and they expect it to get ...

CMR Surgical said it is on track to begin commercialization of its Versius Plus surgical robotic platform in 2026 in the United States.

SleepRes announced today that it received FDA 510(k) clearance for its Kricket PAP device for treating obstructive sleep ...