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.

The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.

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.

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. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.

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.