On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support ...

FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...

Registrar Corp announced the acquisition of TechniCAL, becoming the global compliance leader in shelf-stable packaged foods ...

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...

TechCrunch Disrupt Battlefield 2023 winner, Biotics AI, announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images.

The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) today released the sDHT Adoption Navigator, a comprehensive educational resource designed to help ...

Company’s validation confirms 94.2% accuracy for blood pCO₂ measurement, pivot to standalone configuration opens immediate commercial pathway to global installed base of heart-lung machines and ...

Centauri Health Solutions ("Centauri") today announced that Secure Exchange Solutions (SES), a Centauri product offering, has ...

Many organizations are operating with constrained resources while trying to expand, launch new therapies, or scale manufacturing across regions. At the same time, regulatory expectations and ...

Cellares. Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the ...