Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...

Executives from Aquestive Therapeutics (NASDAQ:AQST) said the U.S. Food and Drug Administration has issued a complete response letter (CRL) for the company’s New Drug Application for Anaphylm, an ...

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 ...

The "Computer System Validation (CSV) Training Course (Jan 27th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering. A course designed to completely immerse you in computer ...

EndoQuest Robotics has received FDA approval to proceed with the final enrollment phase of its pivotal Paradigm trial evaluating a robotic endoluminal system for gastrointestinal procedures. The ...

Rejoni, Inc., a clinical-stage company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and formally filed the Premarket ...

The FDA has issued a Class I recall for GE Healthcare’s Carestation anesthesia systems. Certain Carestation 600 and 700 series anesthesia systems with specific power management boards may shut down ...

Six days after a senior FDA official sent a sweeping internal email claiming that COVID-19 vaccines had caused the deaths of "at least 10 children," 12 former FDA commissioners released an ...

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 ...

Add Yahoo as a preferred source to see more of our stories on Google. Abbott’s range of paediatric heart treatments also includes the Masters HP 15mm mechanical heart valve. Credit: Michael Vi / ...

“Risk is a lens, not a leash. Once teams see what truly threatens patients and processes, the busywork falls away, and quality gets sharper,” said Sindhuri Korrapati, a senior supervisor for software ...