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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Diabetes drug resolves sleep apnea in up to 52% of patients—is FDA approval in the cards?

Based on positive results from two different trials, Eli Lilly and Company hopes to secure a new FDA approval for tirzepatide in the months ahead.

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AI-powered platform for arrhythmia detection gains FDA approval

The newly approved DeepRhythm Platform from Medicalgorithmics uses advanced AI to evaluate imaging results and look for signs of cardiac arrhythmias.

Endotronix, an Illinois-based healthcare technology company, has gained U.S. Food and Drug Administration approval for its Cordella Pulmonary Artery (PA) Sensor System, which uses PA pressure-guided therapy to manage and treat heart failure patients.

FDA approves new pulmonary artery sensor for heart failure

The Cordella platform from Endotronix includes an implantable sensor that tracks the patient’s PA pressure and other helpful health data.

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Heart surgeons are fed up with old technology—many have considered a career change

A majority of U.S. surgeons, including those who treat heart patients on a daily basis, say their operating rooms use outdated technology. It is having a negative impact on patient care. 

Elutia, a Maryland-based healthcare technology company, has received clearance from the U.S. Food and Drug Administration (FDA) for EluPro, its new biologic envelope specifically designed for patients with implantable pacemakers and defibrillators. It was also cleared for use when implanting other types of devices, including neurostimulators and neuromodulators.

FDA clears new drug-eluting envelope for implantable cardiac devices—CEO sees it as ‘tip of the iceberg’

Elutia, formerly known as Aziyo Biologics, is already targeting additional uses for the newly approved device. 

The ASNC team at the 2024 AMA meeting, Georgia Lawrence, JD, ASNC director of regulatory affairs; Suman Tandon, MD, FASNC, delegate to the AMA HOD and cardiac imager at NYU Langone; and Kathy Flood, ASNC CEO. #AMA #AMA24 #AMA2024 #AMAHOD #ASNC

ASNC supports AMA effort to limit use of AI in prior authorization decisions

The American Society of Nuclear Cardiology (ASNC) supports an AMA policy that condemns the use AI to make prior authorization decisions rather than a doctor or clinician.

CDC-funded program improved cardiovascular health of low-income Nebraska women

The WISEWOMAN program proved to be a useful intervention to screen low-income, uninsured women and offer them risk reduction counseling to improve blood pressure, diet and physical activity.

There has been a growing shortage of cardiologists the past several years, but this has accelerated due to burnout from the pandemic, falling reimbursements and increasing administrative burdens. This prompted a joint session on this topic with the ACC and the Heart Rhythm Society at HRS 2024, with ACC President Cathie Biga, MSN, FACC, president and CEO of Cardiovascular Management of Illinois, former ACC president Ed Fry, MD, chair of the Ascension National Cardiovascular Service Line, and EP Parin Patel.

Addressing staffing shortages in cardiology

ACC President Cathie Biga, MSN, RN, Edward Fry, MD, and electrophysiologist Parin Patel, MD, discuss the growing cardiologist shortage.

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Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

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

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.

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