The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.

The U.S. FDA’s program to foster at-home health care is in its early stages and seeks to promote the development of technologies that will enable home health care services.

The U.S. FDA’s device center is working to refine its regulation of artificial intelligence algorithms, but the agency is recommending that industry be more forward-thinking in a blog that urges device makers to fully adopt a life cycle management mindset for these systems.

Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.

U.S. federal preemption of state law for devices approved by the FDA is a matter of record, but a recent case affirms the staying power of Supreme Court jurisprudence on that point.

Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).

The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.

Emvision Medical Devices Ltd. unveiled a portable brain scanning helmet for first responders to quickly identify whether a patient is experiencing a stroke and, if so, what type.

In only the third such change in two decades, the FDA’s device center bids farewell to its director with the announcement that Jeff Shuren will leave the agency in the final weekend of July 2024.

The U.S. FDA accepted Telix Pharmaceuticals Ltd.’s new drug application for TLX-007-CDx, a new cold kit for preparing prostate-specific membrane antigen-PET imaging for prostate cancer.