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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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.

Regulatory Roundup: FDA clears several new solutions, including Apple’s latest AFib offering

The FDA had a busy June, clearing multiple solutions designed to treat patients with cardiovascular conditions. 

June 27, 2022
The Society for Cardiovascular Angiography and Interventions (SCAI) has responded to the U.S. Food and Drug Administration’s (FDA’s) recommendation that all infants and young children who receive iodinated contrast media (ICM) undergo thyroid testing. The group pushed back against this proposal, emphasizing that implementation would have “far-reaching consequences.”

Cardiologists push back on FDA’s thyroid monitoring/contrast media proposal

According to a new SCAI statement, the FDA's recommendation would result in "far-reaching consequences" across multiple specialties. 

June 24, 2022
Product Recall

FDA announces another recall for troubled heart device after a patient death

This latest recall involves the device's batteries, which are separating due to a "welding defect." 

June 23, 2022
The ASNC is one of several medical imaging societies asking Congress to repeal the appropriate use criteria (AUC) criteria mandate. They say it poses issues for clinicians and is becoming outdated by changes in CMS payment systems. The AUC requirements call for documentation using CVMS authorized software in order to show advanced imaging such as nuclear and CT is justified, or else Medicare payments might be withheld.

VIDEO: AMA will ask Congress to revise clinical decision support mandate for cardiac imaging

American Society of Nuclear Cardiology (ASNC) delegates to the American Medical Association (AMA) House of Delegates 2022 meeting Stephen Bloom, MD, and Nishant Shah, MD, explain a new AMA policy asking Congress to revise its clinician decision support mandate. 

June 22, 2022
American Medical Association President Gerald Harmon, MD, explains some of the hottest topics discussed at the 2022 AMA House of Delegates meeting in Chicago. Harmon, a retired Air Force general and family practice specialist, said the top polices adopted where those that addressed gun control, physician burn out and issues regarding scope creep where non-physicians are filling roles traditionally held by doctors. #AMAmtg #AMA175 #AMA #guncontrol

VIDEO: AMA president discusses gun control, physician burnout and scope creep

American Medical Association President Gerald Harmon, MD, joined us for an exclusive chat about some of the hottest topics discussed at the 2022 AMA House of Delegates meeting.

June 16, 2022
contrast shortage

7 ways cath labs can work through the contrast media shortage without delays

When the ongoing contrast media shortage first started impacting health systems, one group in Ohio pledged not to delay a single procedure in its cath labs.

June 15, 2022
Medtronic is once again recalling its HeartWare Ventricular Assist Device (HVAD) pump implant kit, a part of the company’s HeartWare HVAD system. This is a Class I recall, which means using the device can lead to serious injury or death. The new recall includes more than 1,600 devices distributed from October 2006 to June 2021.

FDA announces another recall of Medtronic HVAD pump implant kits—1 patient death reported

The recall includes more than 1,600 devices distributed from October 2006 to June 2021. Medtronic's HVAD system has already been associated with multiple issues, including a separate recall in 2021. 

June 10, 2022
Novavax NVX-CoV2373 COVID-19 vaccine myocarditis

FDA committee backs Novavax's COVID-19 vaccine despite heart damage concerns

The committee's approval comes days after the FDA shared details on a small number of trial participants who developed myocarditis or pericarditis after receiving the vaccine.  

June 9, 2022
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Around the web

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

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

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

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