The U.S. FDA had previously recommended that power morcellation be conducted only with tissue containment systems and has released a draft guidance for non-clinical testing for these containment systems. While the demands for non-clinical testing are rigorous, the draft also said that clinical testing is likely to be required as well, raising the question of why the agency failed to include clinical testing recommendations in the same draft guidance.

The U.S. FDA has granted Sonivie Ltd. IDE approval for a pilot study to treat resistant hypertension patients with renal artery denervation (RDN) using its Tivus ultrasound ablation system. The intravascular, catheter-based system uses high-frequency non-focused ultra-sound energy to ablate nerves in the renal artery and cause denervation of nerves in other structures such as the bronchus.

The U.S. Department of Justice (DOJ) has kept a close eye on medical technology for a number of years, but the department’s consumer protection branch has often lagged behind other DOJ offices where enforcement is concerned.

Quantitative imaging (QI) is making an increasingly larger footprint in clinical practice, and the U.S. FDA has rounded out a 2019 draft guidance spelling out the agency’s expectations regarding technical performance assessment of this class of products. Developers of software that provide quantitative data from imaging studies should expect to conduct studies that ensure the software controls for a wide range of sources of error, suggesting that studies of these algorithms could prove expensive.

Regulatory harmonization for medical technology often seems more the stuff of gauzy dreams than bare-knuckle reality, but the Medical Device Single Review Program (MDSRP) is at the top of the list for a lot of device makers. Jeff Shuren, director of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) device center, told an audience at this year’s annual meeting of the Food and Drug Law Institute (FDLI) that while the agency is very keen on the MDSRP concept, the agency would need help from Congress with the statute in order to take part, and thus the FDA will not be taking part in the MDSRP effort for now.

Up to now, the Pfizer Inc.-Biontech SE COVID-19 vaccine has had a lock on the U.S. pediatric market, for ages 5 to 17, but that could change as early as next week.