Tuesday, January 6, 2026, yielded two surprising updates from the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health. While many experts have been forecasting continued ...

New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food ...

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.

The MAGiC catheter is designed to perform minimally invasive cardiac ablation procedures that treat various forms of ...

In the 1999 sci-fi classic The Matrix, “plugging in” symbolized digital enslavement. In 2025, for a paraplegia patient in ...

For more than 15 years, Aldo Vidinha has worked at the intersection of engineering, quality, and regulatory strategy in the life sciences. His career has taken him across Europe, Asia, the United ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...