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 of nearly 8,000 heart attack tests due to inaccurate results

Overall, the recall includes 7,799 blood tests intended to help physicians identify early signs of a myocardial infarction. 

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CMS includes more payment cuts in 2024 Medicare Physician Fee Schedule proposed rule

CMS also floated the idea of pausing the AUC program until a better implementation strategy could be put into place. 

Video of American Society of Echocardiography (ASE) leadership explaining how the society recognized early the need for standardization and training for on and stepped forward to offer training for various point of care ultrasound (POCUS) users and to bring them into its membership. Image shows a critical care COVID patient being scanned with a Philips Lumify point-of-care ultrasound system with doctors on screen helping guide the user. #POCUS #ASE #ASE2023

ASE training clinicians as point-of-care ultrasound grows

The American Society of Echocardiography recognized the lack of training and standardization for point-of-care ultrasound users and decided to do something about it. 

Medtronic has received FDA approval for its IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

FDA says treating PAD with paclitaxel-coated devices does not increase mortality risk

After warning healthcare providers about a heightened risk of mortality back in 2019, the FDA has now updated its stance on the use of these devices. 

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FDA asked to investigate ‘eye-popping’ amount of caffeine in Logan Paul’s Prime energy drinks

Should an energy drink with more caffeine than five cans of soda be marketed to kids? Sen. Chunk Schumer shared his concerns in a new letter to FDA Commissioner Robert Califf, MD, a veteran cardiologist. 

FDA approves Abbott’s Aveir dual chamber (DR) leadless pacemaker system, the world’s very first dual chamber leadless pacing solution for treating patients with abnormal heart rhythms.

FDA approves world’s first dual-chamber leadless pacemaker system

The minimally invasive system is made up of two pacemakers that send signals back and forth to one another. One pacemaker is placed on the patient's right ventricle, and the other is placed on the patient's right atrium. 

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Cardiology societies say affirmative action ruling will do long-term damage to patient care

The American College of Cardiology, Association of Black Cardiologists and several other U.S. societies released a new joint statement on the ruling.

Cardiologists, radiologists say EPA’s new sterilization proposal could put patients at risk

The primary concern is that sterilization facilities and healthcare providers would not have enough time to adapt to the proposal. Devices impacted would include pacemakers, angioplasty balloons and catheters, just to name a few. 

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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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