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.

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. 

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.

Newsweek ranked the 50 best heart hospitals in the world

10 key updates from new American College of Cardiology inpatient heart failure recommendations

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.

Cardiologist Ami B. Bhatt, MD, a digital health specialist and longtime member of the American College of Cardiology (ACC), will serve as the Digital Health Advisory Committee's very first chair.

Cardiologist to chair new FDA advisory committee focused on AI, other digital health technologies

The Digital Health Advisory Committee is tasked with providing perspective and recommendations on a wide variety of topics. These insights will then help the FDA draft new policies and make other important decisions.

Dan Blumenthal, MD, MBA, chief quality officer at the Cardiovascular Associates of America, and a cardiologist at Massachusetts General Hospital, spoke at the Heart Rhythm Society (HRS) 2024 meeting business sessions on how changes in Medicare payments will impact electrophysiology and cardiology more broadly.

What cardiologists should expect as U.S. healthcare payment models evolve

Cardiologist Dan Blumenthal, MD, MBA, explains how changes in Medicare payments will greatly impact cardiology in the years ahead. In just a few short years, the business side of cardiology could look substantially different than it does today. 

doctor examines patient data on their tablet

FDA sees potential in new PET imaging agent for cardiac amyloidosis

Early evidence suggests a new PET imaging agent from California-based Attralus can help evaluate all varieties of systemic cardiac amyloidosis. It has now been granted the FDA's breakthrough therapy designation. 

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

 

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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