The agency has asked for an additional phase 3 study before it considers another application from manufacturer Lykos.

Physicians using the Paradise Ultrasound Renal Denervation system from Recor Medical or Symplicity Spyral Renal Denervation system from Medtronic will soon be eligible for a much more significant reimbursement when treating Medicare patients in an inpatient setting. 

Around two-thirds of all approved artificial intelligence-powered clinical devices are catered to radiology settings.

The Neffy nasal spray was shown to be as effective as injectables in four studies on 175 adults.

The agency is gathering feedback on a proposal to double the amount hospitals are paid for coronary computed tomography angiography, with the comment period ending Sept. 9.

The American College of Cardiology, American Heart Association and Heart Failure Society of America worked together on the updated document, adding three new performance measures and six new quality measures. They did not remove a single recommendation from the previous document published in 2020.

The collaboration is centered on integrating Alara’s dose tools, which ensure radiation doses are accurately measured and optimized to prioritize patient safety, with Bayer's Calantic Digital Solutions platform.

The new expert consensus decision pathway replaces a similar document from 2019 and is to be used in conjunction with heart failure guidelines published in 2022 by the ACC, American Heart Association and Heart Failure Society of America.