Hologic Inc.’s focus on women’s health is looking like a brilliant move as the company lands U.S. FDA clearance for its Genius digital diagnostics system with the Genius cervical artificial intelligence algorithm, making it the first digital cytology system with clearance, the company said.
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
Cognito Therapeutics Inc. closed a $35 million extension to the series B fundraising round it started in 2023, bringing the total for the round to $108 million and the total funding to date to $128 million. Cognito is developing Spectris, a wearable medical device that provides visual and auditory stimulation for the treatment of Alzheimer’s disease and other neurological disorders.
The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
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 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.
In keeping with federal standards for classifying race and ethnicity data, the U.S. FDA issued a draft revision to broaden its 2016 guidance on the collection of such data in clinical trials.
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.