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. 

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FDA announces Class I recall after insulin pump software causes 224 injuries

The new recall impacts more than 85,000 devices. If users update their iPhone app as recommended, however, they can continue using the insulin pump as directed. 

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FDA warns against use of troubled heart devices, citing ‘continued concerns’ after multiple recalls

The agency is urging healthcare providers to transition away from these devices and seek out alternatives. It is even working with other manufacturers to try and get similar products on the market as quickly as possible. 

Jeff Kuvin, MD, explains the effort to create an new independent cardiology board. He is the ACC point person for the effort.

The push for an independent cardiology board continues

Jeffrey Kuvin, MD, one of the leading voices behind efforts to create a new Board of Cardiovascular Medicine, spoke with Cardiovascular Business about where things stand today.

ACC President Cathie Biga explains how cardiologist employment models undergoing a profound transformation during an interview with Cardiovascular Digital Editor Dave Fornell at ACC 2024.

What happened to cardiology's private practices?

Hospital employment models, reimbursement policies and private equity have all led to a massive reduction in the number of cardiologists working for a private practice, ACC President Cathie Biga, MSN, told Cardiovascular Business.

When Apple previewed its watchOS 9 update in early June, one of the key features the company highlighted was a new tracking option for atrial fibrillation (AFib) patients. The AFib History feature, approved for patients 22 years and older who have been diagnosed with AFib, was designed to help users gain a better understanding of their symptoms and easily share data with healthcare providers.

Apple Watch AFib feature becomes first-ever digital tool approved by FDA to evaluate medical devices

Healthcare technology companies can now use AFib findings recorded by an Apple Watch to help demonstrate the effectiveness of their devices to the FDA.

Cardiologist Foluso Fakorede, MD, explains the most common health disparities he sees preventing care in rural Mississippi. #PADadvocate #PAD #CLI #CLTI #Healthdisparities #HealthdisparitiesMS

Cardiologist details the many health disparities he encounters in rural Mississippi

Foluso Fakorede, MD, an interventional cardiologist with Cardiovascular Solutions of Central Mississippi, says these issues are typically overlooked in today's healthcare environment. 

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‘Concerning’ data connect industry payments to cardiologists with medical device use

U.S. physicians often receive payments from medical device manufacturers and pharmaceutical companies. New research in JAMA found a connection between receiving such payments and using specific devices—should the industry be concerned? 

Abbott's Espirit BTK Everolimus Eluting Resorbable Scaffold gained U.S. FDA approval in April 2024. It is based on the former Abbott Absorb coronary stent, but indicated for use in peripheral artery lesions below the knee (BTK).

FDA approves Abbott’s resorbable stent for BTK arteries

The bioresorbable stent, examined at length for the LIFE-BTK clinical trial, stays in place for up to three years before completely dissolving. 

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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