Dublin-based Medtronic plc has snagged the U.S. FDA’s approval for its Micra AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. The company said it will begin rolling out the device at a limited number of medical centers in the upcoming weeks, with a full, nationwide launch at some point this spring.

Novel imaging, AI combo enables rapid and accurate brain tumor diagnosis during surgery

Unlike with other kinds of cancer, there’s no opportunity for a biopsy ahead of surgery for a suspected brain tumor. Neurosurgeons examining a mass in the brain must determine if a tumor is cancer and precisely what kind of brain cancer it is during surgery. The latter is crucial because it helps to determine the best surgical plan to subsequently follow. Researchers now have developed a novel approach that combines a new, commercially available imaging technology, stimulated Raman histology, with an artificial intelligence algorithm to offer a diagnosis of brain tumors in just a couple of minutes. They published the results of a study in the Jan. 6, 2020, issue of Nature Medicine that determined their approach was noninferior to standard pathologist interpretation of histologic images.

FDA, Congress still on hold regarding regulation of lab-developed tests

A new report by the Congressional Research Service revives the question of U.S. FDA regulation of lab-developed tests (LDTs), a question that has been in play for several years. Regulatory attorney Jeffrey Shapiro of Hyman Phelps & McNamara PC told BioWorld that the FDA is no longer in a position to unilaterally impose a regulatory regime on LDTs, and there is little likelihood that any enabling legislation will pass until at least 2021.

French university hospitals grasp AI

PARIS – EY SAS has published the results of the first edition of a barometer dedicated to the role of artificial intelligence (AI) in French public hospitals. The health care sector, which is undergoing wholesale change in France, is suffering tight economic constraints and faces ever-increasing expectations from patients. “The development of [AI] in France is a priority. It's a matter of gauging it,” Loïc Chabanier, an EY partner responsible for health care, told BioWorld.

‘Oncogene’ Ras has memory functions

Remember how Ras is the most frequently mutated oncogene in solid tumors? Well, it turns out Ras plays a role in those memories, too. In the Jan. 13, 2020, issue of the Proceedings of the National Academy of Sciences, scientists at the Scripps Research Institute in Juniper, Fla., reported on the discovery that Ras signals through Raf and then Rho kinase to control whether memory is short or long-term.

Also in the news

3B Scientific, Airos Medical, Akers Biosciences, Aortech International, Atf Medical, Atl Technology, Avivagen, Avomd, Axonics, Cambridge Clinical Laboratories, Centese, Cerus, Eyenuk, Gentherm, Human in Motion Robotics, Inotrem, Isimulate, Jmeds, Miach Orthopaedics, Myriad, Nevro, Novigenix, Novocure, Otsuka Pharmaceutical, Phoremost, Predictimmune, Resaphene Suisse, Ra Medical, Revian, Rua Medical, Soundbite, Stimguard, Transenterix, Varian, Venus Medtech, Vivalnk