Ultrasound AI, a pioneer in artificial intelligence applications for medical imaging, today announced it has received FDA De ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

The MarketWatch News Department was not involved in the creation of this content. Dallas, Texas--(Newsfile Corp. - February 5, 2026) - MedCognetics, Inc., a company focusing on medical imaging AI, ...

The Fluido compact fluid warming system. [Image from TSC Life] TSC Life announced that it received FDA clearance for its Fluido Compact fluid warming system for pediatric use. Pediatric clearance ...

ValGenesis, Inc., the global leader in enterprise digital validation and compliance solutions, today announced that GAMP Services Private Limited, a technology and consulting firm based in India, has ...

ValGenesis Inc., the global leader in digital validation lifecycle management, today announced that a leading vaccine manufacturer will use its platform to digitalize and standardize equipment ...

Cell and gene therapies (CGTs) are shaping modern medicine by targeting diseases at their source through cellular and genetic modifications. The true game-changer for such therapies will lie in ...

In pharmaceutical manufacturing, software validation is innovation’s silent killer. A single user requirements specification (URS) takes weeks. Test plans stretch for months. Change controls bog down ...

The U.S. Government Accountability Office says the Food and Drug Administration (FDA) has made significant progress implementing a major food safety law passed in 2011 but has not adequately assessed ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an international ...

Phase III is intended to generate meaningful biological data on potential drug compounds prioritized by YuvaBio’s classifier, which applies proprietary machine-learning methods to identify candidates ...