Bioserenity SAS has gained U.S. FDA clearance for the Neuronaute electroencephalography (EEG) system and Icecap EEG wearable device, which aim to help physicians remotely monitor and assess electrical brain activity of people with epilepsy. The company noted that the Icecap and Neuronaute system will facilitate access to care in a variety of settings, including rural and remote environments.

The U.S. FDA’s safer technologies program, or STeP, is designed in part as a complement to the breakthrough devices program, but the September 2019 draft guidance lent little clarity as to what might constitute a significantly safer device. The Jan. 5, 2021, final guidance does little to clarify that question, however.

The medical device company Distalmotion SA has hit a regulatory milestone in the commercialization of its surgical robot, Dexter, earning a CE mark in Europe. The Dexter surgical robot is built with the aim of allowing surgeons to take a hybrid approach to minimally invasive surgery, using the robot for tasks such as suturing and complex dissections while switching to a laparoscopic approach for stapling and basic dissections.

The U.S. FDA’s device center may still be grappling with the COVID-19 pandemic throughout the remainder of fiscal year 2021, but that does not mean other considerations have disappeared. The FDA’s Erin Keith said the agency will keep working on a major overhaul of the quality systems regulation (QSR) but will also work toward expanding industry’s use of advanced manufacturing technologies, such as additive manufacturing.

As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.