Here’s a breakdown. If a product claims it’s “FDA-registered,” it doesn’t apply any form of approval, clearance, or endorsement. Registration simply means the manufacturer has filed thei ...

The FDA cleared Ibex Prostate Detect, an artificial intelligence tool aiding prostate cancer detection. The FDA has granted a 510(k) clearance to the Ibex Prostate Detect software (formerly Galen ...

FDA clearance marks a significant milestone for Ibex Medical Analytics, supporting the clinical adoption of AI-powered digital pathology solutions. The AI tool demonstrated high accuracy in detecting ...

FDA clearance affirms Ibex’s position as a global leader in AI-powered cancer diagnostics Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has ...

BOSTON, February 10, 2025--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA ...

FDA clearance affirms Ibex’s position as a global leader in AI-powered cancer diagnostics BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today ...

11, 2025 /PRNewswire/ -- On 12 Feb 2025 (Singapore Time), Lion TCR announced that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S ...

TORONTO, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory ...

Ongoing proof-of-concept (PoC) clinical trial in pain associated with pancreatic cancer with topline data on track for 1H 2025Continued solid ...

NEW YORK – Ibex Medical Analytics on Monday said the US Food and Drug Administration granted 510(k) clearance to its in vitro diagnostic device Ibex Prostate Detect, which uses artificial intelligence ...

Nuance Audio will be available for purchase in the U.S. beginning in Q1. Paving the way for a disruptive new category in the med-tech space, Nuance Audio Hearing Aid Software is the first FDA cleared, ...

Beyond Stargate's big players, a growing number of innovators have been revolutionizing healthcare by making recent ...