The Biden administration recently announced an extension of the comment period for a request for information on harmonization of cybersecurity regulation, a proposal that could conflict with FDA regulation of medical device cybersecurity.

Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.

Boston Scientific Corp. has managed its Polarx device to another regulatory approval, this time a nod from the U.S. FDA, giving the company access to one of the world's premier markets. The news comes four months after the company obtained a CE mark for the device, opening the door to two jumbo markets in a move the company hopes will ensure the device will provide solid returns on its investment.

Peijia Medical Co. Ltd. reported the implant of its Taurustrio transcatheter aortic valve replacement (TAVR) system in a first patient as part of a multi-center trial getting one step closer to launching the first TAVR system for aortic regurgitation (AR) in China.

Mdoloris Medical Systems SAS reported it has developed an automated system for regulating perioperative pain based on continuous optimization of parasympathetic tone. Closed-loop control systems are still rare in the anesthesia space, but they provide greater reliability in achieving set objectives, reduce the risk of human error and free the anesthesiologist from the burden of manually adapting the administration of the various therapies required for surgery.