BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) ...

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...

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 ...

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...

Korea's first fully automated diagnostic system capable of simultaneously detecting 16 major foodborne pathogens within one ...

Clearance extends Pearl's FDA-validated radiologic AI platform to enable real-time detection of key dental pathologies across the world's most widely used type of extraoral radiograph.

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial ...