News

Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) ...
Aktiia, a pioneer in optical blood pressure monitoring, announced today that it has received U.S. Food and Drug ...
The burden then shifts to hospitals, which puts clinicians in a tough spot, relying on AI that might not generalize, with no ...
Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease ...
Avant Technologies Logo (PRNewsfoto/Avant Technologies Inc.) The pre-submission ... trial and to support the Company's FDA 510(k) submission to obtain clearance from the FDA to market the Vision AI ...
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Unlike expensive positron emission tomography (PET) scans or invasive lumbar punctures, the new blood test measures the ratio ...
Quest Diagnostics has signed up to offer a blood test that can help diagnose Alzheimer’s disease, following its FDA clearance earlier this year. | The Lumipulse G blood test measures the ratio between ...
Synchrony Medical announced that it received FDA 510 (k) clearance for its LibAirty airway clearance system.
PathPresenter, a leading Image Management System and workflow platform for digital pathology, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the PathPresenter Clinical ...
Drugmaker Sarepta Therapeutics says it won't comply with a request from U.S. regulators to halt all shipments of its gene ...
The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.