A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...

Dynamic AI systems applied in biopharmaceutical manufacturing must be governed within established regulatory frameworks.

A model may perform exceptionally well and still lack the evidence package necessary to support regulatory review.

Patent attorney Jay Halt explains how medtech companies should align IP strategy with FDA compliance to avoid unenforceable patents and regulatory issues.

BOSTON--(BUSINESS WIRE)--ZETA SURGICAL today announced that its Zeta TMS Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a ...

Reed, PhD, named to the 100 Women in AI 2026 list, champions strict healthcare AI validation over simple administrative ...

Despite shifts in key compliance frameworks and ongoing digitalisation across the entire pharmaceutical value chain, many organisations still rely on paper-based legacy systems and siloed compliance ...

Throne Science, an Austin startup whose AI-powered toilet camera launched to consumers just four months ago, has closed a $10 million Series A round — funding the one health-monitoring category that ...

Inner Logic autonomous surgical simulation platform raises $11.5 million to replace cadaver labs with overnight virtual ...

Discover how New Approach Methodologies (NAMs) can play a role in food safety testing, producing more human-relevant results ...

Stroke patients who arrive at a hospital with a large blood clot blocking a major brain artery now have a new treatment ...