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.

Vektor Medical Inc. recently secured CE mark for Vmap, its AI-powered electrocardiogram mapping system, marking a “major milestone” for the company, said CEO Rob Krummen. The regulatory approval from the EU authorities confirms that Vmap meets the stringent safety and performance requirements of the EU Medical Device Regulation, opening the door for clinical use in Europe, he told BioWorld.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) reported that it will seek to deepen its collaboration with other regulators, a list that includes but is not limited to the FDA. MHRA said that the U.K.-U.S. reliance program would apply to not only class II devices under the 510(k) and de novo programs, but to class III PMA devices as well, promising a somewhat more streamlined path to a market ripe with opportunity for the devices and diagnostics industries.