Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Siemens Healthineers gains FDA clearance for new AI-powered cardiovascular ultrasound system

The Acuson Origin system includes advanced AI algorithms designed to assist users with the treatment of diagnostic, structural heart, vascular, electrophysiological and pediatric patients. It also comes packaged with a new 4D ICE catheter capable of multiplanar reconstruction imaging with or without the use of an electrocardiogram.

Dana Smetherman, MD, ACR CEO, explains AUC may be better than prior authorizations.

ACR CEO discusses solution to fight burdensome prior authorizations in medical imaging

Dana Smetherman, MD, MBA, outlines a possible remedy for the growing number of these roadblocks in the specialty. 

MDMA Ecstasy

FDA rejects ‘ecstasy’ as treatment for PTSD

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

Recor Medical's Paradise Ultrasound Renal Denervation System

CMS increases inpatient payment for Recor Medical, Medtronic renal denervation systems

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. 

artificial intelligence

FDA adds dozens of AI-enabled radiology applications to list of clearances

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

FDA approves epinephrine nasal spray for anaphylaxis

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

CMS may double Medicare payments for cardiac CT

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.

physician tracking patient data and reporting on outcomes

Cardiology groups introduce new performance, quality measures for heart failure

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.