Boston Scientific Corp. resumed enrollment in the AVANT GUARD trial of the Farapulse pulse field ablation (PFA) system after a pause reported in October “to assess a few unanticipated observations.” The trial aims to expand the indications for the market-leading PFA system to include a new population, drug-naïve patients with persistent atrial fibrillation. Read More
Momentis Surgical Ltd. received 510 (k) clearance from the U.S. FDA for the second-generation of the Anovo robotic surgical platform. The upgraded system allows surgeons to experience enhanced ergonomics with integrated haptic feedback, creating more intuitive control of the robotic arms during surgical procedures. Read More
Abstract ideas are not generally eligible for patents in the U.S., but a recent dispute heard by the U.S. Patent Trial and Appeal Board adds a new twist to the question. Read More
The U.S. FDA’s Nov. 1 warning letter to Owens & Minor Inc. criticized the company for a lack of documentation that two components of convenience kits had been validated for sterilization with ethylene oxide. Read More
Six main cell types form glioblastomas (GBM), the most aggressive brain cancer due to its high rate of recurrence. Of these six, quiescent cancer stem cells are responsible for resistance to therapy and the reappearance of the tumor, according to a study that identified the six groups and highlighted the importance of these stem cells for the design of more effective therapies. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alverno Laboratories, Avertix Medical, Boston Scientific, Cardinal Health, Datafirst, Everlight, Ibex Medical, Inflammatix, Johnson & Johnson, Jubilant, Mainz Biomed, Seno Medical Instruments, Simplified Imaging Solutions, Thermo Fisher Scientific, Vizient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Techne, Egeneis, Icad, Magstim, Nevro, Organox, Philips, Quantalx. Read More