CMS hesitates to approvePET for cancer despite data
Despite data indicating PET can influence the management of cancer patients regardless of their cancer type, National Oncologic PET Registry scientists faced a setback when the Centers for Medicare and Medicaid Services reviewed a request for expanded coverage.
Despite data indicating PET can influence the management of cancer patients regardless of their cancer type, National Oncologic PET Registry scientists faced a setback when the Centers for Medicare and Medicaid Services reviewed a request for expanded coverage. A CMS advisory panel came to the conclusion that clinical data for nine conditionally approved cancer indications of FDGPET were too ambivalent to support the petition.
The NOPR team suggested that making decisions case by case would be counterproductive. They remain optimistic that CMS will look favorably at the latest findings before making a final coverage decision, which is scheduled for January.
BrightHeart Garners Third FDA Clearance for AI-Powered Assessments of Fetal Heart Ultrasound
May 14th 2025The latest FDA 510(k) clearance is for B-Right Views, an AI-enabled device, which provides automated detection of required views necessary for second- and third-trimester fetal heart ultrasound exams.
