The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker’s Incompass Total Ankle System, designed ...

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “ANDAs: Pre-Submission Facility ...

ENDRA is committed to generating the additional data required for the De Novo process as rapidly as possible in 2022, building on substantial portions of ENDRA’s completed 510(k) submission.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Viz.ai for its Viz Subdural Plus module, designed for enhancing clinical decision-making. It is claimed to be the first ...

Rhythm Technologies, Inc.'s Q1 2025 growth, AI innovations, and market expansion. Click for why I upgraded IRTC to Buy despite FDA risks and profitability issues.

SAN FRANCISCO--(BUSINESS WIRE)--Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k ...

Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz Subdural Plus ...

The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer ...

NEW YORK – Lex Diagnostics announced Friday that it has submitted its point-of-care molecular diagnostics system along with a test to detect influenza A, influenza B, and COVID-19 to the US Food and ...