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.

Thermoablation of thyroid nodules meets the patient’s standard of minimal invasiveness and is supported by the literature as an effective treatment for these nodules, which may become cancerous.

Artificial intelligence might solve a world of cost issues for medical science, but the results of a recent study suggest that the day has not yet come when hospitals and doctor’s offices can just feed data into a computer and expect a reliable and intelligible diagnosis.

Regulation of artificial intelligence for medical devices is still a developing space, but market competition authorities in the European Union, the U.K. and the U.S. are already examining the potential for anticompetitive behavior in this rapidly growing technological arena.

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 literally wasted no time in posting twin warning letters to two companies in China that manufacture syringes that were the subjects of multiple recalls in the U.S.

The U.S. FDA cited Criticare Technologies Inc. for significant lapses in the company’s corrective and preventive action procedures, which suggests a need for outside certification of compliance because this problem was also observed in a warning letter from 2017.

The U.S. Patent and Trademark Office has provided updated guidance on the question of patent subject matter eligibility for inventions that rely on artificial intelligence, stating that a patent claim that does little more than recite an abstract idea is not subject-matter eligible.