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.

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.

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.

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.

Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.

Zap Surgical Systems Inc. reported closing a $78 million series E funding round led by Qingdao Baheal Medical Inc., with participation from other strategic investors. The new funds will be used to commercialize the company’s Zap-X gyroscopic radiosurgery platform for the non-invasive treatment of brain tumors.

The U.S. Government Accountability Office has rejected an appeal by MCI Diagnostics Inc. regarding a contract bid with the Department of Veterans Affairs despite the company’s assertion that the VA pricing mechanism is flawed.

Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.