FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...

Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...

The FDA announced that it removed a limitation on the use of real-world evidence (RWE) in drug and device application reviews ...

Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical ...

Building FDA submissions like a solid house requires early collaboration, proactive planning, and a clear regulatory story.

Nephrodite, Inc., a medical device company developing an implantable, continuous renal replacement system, today announced ...

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be ...

The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...

Flow Neuroscience announced that the FDA approved its Flow at-home brain stimulation device for treating major depressive ...