The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.

Japan is reimagining how mental health care can be delivered digitally and proactively, with local governments investing in digital technology to create data-driven safety nets that aim to detect distress and deliver help, presenters said during the Bio Japan 2025 conference in Yokohama, Oct. 8 to 10.

John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning (ML) patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.

While recent advances in gene therapy have offered unprecedented options for patients with hemophilia, new data presented at the 32nd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), held in Seville Oct. 7-10, revealed persistent concerns regarding the durability of these treatments and their potential liver toxicity.

Pulse Biosciences Inc. presented late-breaking results from its successful first-in-human study of its nanosecond pulsed field ablation technology in treating atrial fibrillation at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. The Hayward, Calif.-based company’s Npulse cardiac surgical system takes PFA technology into the cardiac surgery setting.