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.
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.
LONDON – Three years after the implementation of new U.S. legislation requiring clinical trials to report results within 12 months of completion, more than half are not published on time and compliance is not improving.
Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.
The U.S. FDA has granted breakthrough device designation to Mojo Vision Inc. for its first-of-a-kind true smart contact lens. The Mojo Lens, which features “invisible computing” and a built-in display, enables people to get timely information without having to look away from what they are doing or glance at a screen.