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 sometime this spring. About the size of a large vitamin pill, the leadless Micra AV is indicated for the treatment of patients with AV block, a disorder that occurs when the electrical signal traveling from the atria, or upper chambers of the heart, to the ventricles, or lower chambers, is impaired. Read More
Unlike with other kinds of cancer, there’s no opportunity for a biopsy ahead of surgery for a suspected brain tumor. To help matters, researchers have developed a novel approach that combines a new, commercially available imaging technology – stimulated Raman histology (SRH) – with an artificial intelligence (AI) 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. Read More
A new report by the Congressional Research Service (CRS) revives the question of U.S. FDA regulation of lab-developed tests (LDTs). However, attorney Jeffrey Shapiro, of Washington-based Hyman Phelps & McNamara PC, told BioWorld that the agency is no longer in a position to unilaterally impose a regulatory regime on LDTs, and that there is little likelihood that any enabling legislation will pass until at least 2021. Read More
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. Read More
Remember how Ras is a frequently mutated oncogene in solid tumors? Well, it turns out Ras plays a role in those memories, too. In the Jan. 13, 2020, online 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. Read More
