The U.S. Food and Drug Administration highlighted concerns about "data drift," which can potentially lead to performance degradation, bias or reduced reliability.
This uptick was attributed to more scans being administered per ED visit, rather than a rise in overall patient volumes, an analysis of Medicare data found.
Also, Hologic expected to generate $800M in free cash flow, full-body MRI startup raises $27M, and the FDA clears solutions from Hyperfine, Subtle Medical and Positrigo.
An updated version of Heartflow's Plaque Analysis platform has gained FDA clearance. In addition, the company announced that Cigna will cover the platform going forward.
Several groups collaborated on the document, which is designed to help clinicians provide high-quality, consistent care when using flurpiridaz during cardiac PET imaging exams.