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. 

Mark Rabbat, MD, director of cardica CT at Loyola, discusses legislative advocacy efforts by SCCT to gain wider reimbursement for cardiac CT. #SCCT #SCCT23 #SCCT2023

SCCT hopes to increase cardiac CT reimbursements through advocacy

Mark Rabbat, MD, discusses the Society of Cardiovascular Computed Tomography's efforts to make an impact by lobbying in Washington. 

AI artificial intelligence stethoscope doctor

FDA clears AI model for detecting signs of heart failure in ECGs

The advanced AI model, developed by Anumana with help from Mayo Clinic, could provide value as a screening tool for heart failure.

cardiologists going through the certification process

Q&A: A closer look at the push in cardiology for a new, independent American Board of Cardiovascular Medicine

American College of Cardiology President B. Hadley Wilson, MD, discussed why the ACC and other leading cardiology groups are so eager to create a new, independent medical board. This has been a long-term goal for many years, he said, and now it may become a reality. 

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Time for a change? Cardiology groups announce plan to develop a new medical board independent of the ABIM

"We know that the cardiovascular community is ready for an independent, self-governed entity, and we are proud to develop this new board with cardiologists and cardiology organizations at the helm," ACC President B. Hadley Wilson, MD, said in a statement.

Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

Cooling device now approved by FDA to reduce risk of ablation-related esophageal injuries

Already approved for temperature management, the single-use ensoETM device is now cleared for another use: minimizing the risk of potentially fatal injuries to the patient's esophagus during radiofrequency ablation procedures. 

Video of Denise Garris, ASE regulatory consultant and principal of the Korris Group, explaining how reimbursements from insurance andMedicare work to pay or cardiac ultrasound exams. #ASE #ASE360 #ASE23 #ASE2023 #healthcarereimbursment

Understanding reimbursements and coding for echocardiography

"I think everyone would agree that the current fee-for-service model is not working appropriately and there needs to be a fix," regulatory consultant Denise Garris explained in a new interview. 

FDA approves LimFlow System for Transcatheter Arterialization of Deep Veins for CLTI

FDA approves new minimally invasive CLTI treatment for ‘no-option’ patients at risk of amputation

The new device, the first of its kind to gain FDA approval, was designed for patients who have no other endovascular or surgical options available to them.

Medtronic faces lawsuit for sharing data of customers who used the InPen smartphone app

Medtronic faces class-action lawsuit after patient data shared with Google, other third-party sites

The complaint describes Medtronic's actions as “immoral, unethical, oppressive and unscrupulous.”

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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