The U.S. FDA added a second pulsed field ablation (PFA) system to the approved list with its greenlight for Boston Scientific Corp.’s Farapulse for treatment of atrial fibrillation (AF). Farapulse joins Medtronic plc’s Pulseselect, which garnered FDA approval in December. Two other PFA devices scored regulatory wins since the new year: Biosense Webster inc.’s Varipulse secured approval from the Japanese Ministry of Health Labor and Welfare and Sichaun Jinjiang Electronic Medical Device Technology Co. Ltd. got the nod from China’s National Medical Products Administration.

The U.S. FDA’s latest draft guidance for the use of real-world evidence (RWE) is a substantially heftier document than the 2017 final guidance that will shortly become obsolete, and buried in all those extra pages are a few key details.

The U.S. FDA has redrafted an existing guidance for third-party reviews of 510(k) submissions to include submissions under the emergency use authorization (EUA) program, which generally speaking should be good news. The problem with the draft is that these third parties will have to interact frequently and substantively with the FDA in EUA reviews, and the lack of prescribed timelines in the FDA draft suggests that while the use of third parties may help the agency manage any future EUA workloads, the total turnaround time for these applications might not be significantly better than was seen during the COVID-19 pandemic.

Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.

Ascidian Therapeutics Inc. has received FDA clearance of its IND application for ACDN-01, an RNA exon editor targeting the genetic cause of Stargardt disease.

Neuralace Medical Inc. tied up a second U.S. FDA clearance for its Axon therapy, adding painful diabetic neuropathy (PDN) to the chronic nerve pain indication it received in 2021. An ‘electroceutical’ device, Axon employs non-invasive magnetic peripheral nerve stimulation (mPNS) to provide relief without leads, injections or implants.

Becoming the first treatment for children ages 1 to 11 with eosinophilic esophagitis (EE), Sanofi SA and Regeneron Pharmaceuticals Inc.’s IL-4/IL-13 inhibitor Dupixent (dupilumab) was cleared by the U.S. FDA on Jan. 25.

Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday.

The U.S. Department of Justice (DOJ) has announced a conviction obtained in federal court of an employee of a medical device manufacturer who was charged with forging documents that purported that his employer had obtained clearance for two medical devices. Peter Stoll III, who was employed by Aesculap Inc., of Center Valley, Pa., will serve 12 months in prison and a year of supervised release in one of the most egregious examples of fraudulent med tech behavior in recent memory.