Physicians may not be aware of such devices' intended use, with potential for misdiagnosis resulting in patient injury or death, the agency announced. 

Merit Medical Systems claims its system is the first wire-free solution providers can deploy during such MRI-based procedures. 

The imaging group has reportedly applied for leniency with the antitrust division, cooperating with the DOJ in exchange for avoiding prosecution. 

The Society for Nuclear Medicine & Molecular Imaging expressed "strong opposition" following CMS' decision, arguing there is no evidence to support limiting pay for such scans. 

Now valued at $1.2B, the San Francisco startup was co-founded by a neurosurgeon and offers a suite of solutions for diagnosing diseases from medical images. 

The agency has maintained the same pay restrictions in its final policy, only covering PET scans if required by a clinical trial protocol. 

Quality improvement efforts have sought to address such low-value diagnostic testing in the ED, with little attention paid to ambulatory settings, experts wrote in JAMA. 

ACR and others have submitted a formal national coverage determination request, asking the agency to address payment gaps for virtual colonoscopies.