The new device, the first of its kind to gain FDA approval, was designed for patients who have no other endovascular or surgical options available to them.

About 10% of these cases required immediate or urgent action, researchers detailed in Clinical Imaging. 

The administration also is accepting comments on the draft guidelines and plans to host a webinar on Oct. 26. 

The complaint describes Medtronic's actions as “immoral, unethical, oppressive and unscrupulous.”

The American Society of Nuclear Cardiology is pushing payers to more consistently and correctly cover medically necessary scans without prior authorization. 

The federal agency first announced the move Tuesday, noting that it pertains to single and bundled payment disputes submitted on or before Aug. 3. 

The rule would establish a list of “at least 50” shoppable radiology exams for which providers must publicly disclose pricing on their websites.

The Amsterdam-based imaging industry giant emphasized that the agreement “does not include or constitute any admission of liability, wrongdoing or fault.”