Browsing Tag

Food and Drug Administration

Viz.ai Receives FDA 510(k) Clearance for Viz SDH

AI-powered Viz SDH automatically detects subdural hemorrhage, enables effective triage and optimal care Viz.ai, the leading AI-powered disease…

EUA is based on data that show children 5 through 11 years of age had a robust immune response with a favorable safety profile following a 10-µg…

FDA decision supported by an interim clinical study report on patient safety Virtual Incision Corporation, a medical device company pioneering…

Product Received Fast-Track Designation for military personnel facing the potential threat of exposure to synthetic opioids on the battlefield on…

New data shows improved deep learning algorithm performs equally across all age groups, enabling more patients to benefit from the company's cardiac…

GE Healthcare announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help…

- Second Fast Track Designation for Nemvaleukin - Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track…

Second Dupixent (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2…

● Expanded menu of innovative AI-powered decision support tools benefits pathologists and patients through enhanced quality of diagnosis ● Joint…

PeraHealth, Inc., a software company that uses the Rothman Index to transform clinical decision support and improve efficiency in healthcare,…