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CapsoVision submits FDA 510(k) for AI-assisted module in CapsoCam Plus

CapsoVision, Inc. CV recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based reading feature to its CapsoCam Plus capsule endoscopy system. The ...
BioWorld

FDA clears Artrya’s Salix AI coronary plaque module

The U.S. FDA has cleared Artrya Ltd.’s 510 (k) for its Salix Coronary Plaque (SCP) module that is a bolt-on module to the company’s Salix coronary anatomy platform.
Business Wire

Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment

DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a pioneering artificial intelligence (AI) company transforming oncology drug discovery and development, today announced the launch of an ...
JD Supra

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing ...