The prognostic test stratifies hospitalized women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia.

The FDA has granted a 510 (k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read). The Ibex Prostate ...

Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect, an ...

Please provide your email address to receive an email when new articles are posted on . The FDA has granted 510(k) clearance to a Bay Area commercial stage medical technology company for its novel ...

AI Optics, an AI-focused medical device company, has received FDA 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system. The Sentinel Camera aims to address critical gaps in ...

NEW YORK – The US Food and Drug Administration in December granted 510(k) marketing clearances to molecular tests for infectious diseases, an updated digital pathology system, and immunoassays for ...

has granted 510(k) clearance for the Aptiva ® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents. Aptiva utilizes particle-based multi-analyte technology ...

CLI tool to initialize a React Native application with Expo. Provides options to include Typescript, file-based routing via Expo Router, configuration based routing via pure React Navigation, styling ...