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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Boston Scientific TAVR ACURATE Prime Aortic Valve System

Boston Scientific’s new TAVR valve gains CE mark approval

The self-expanding Acurate Prime Aortic Valve System was designed with improved valve positioning in mind. According to Boston Scientific, it it will be available in more sizes than the company's previous TAVR device to ensure it can treat as many heart patients as possible. 

Medicare coverage for weight loss drug semaglutide could cost up to $145B per year

Medications that target obesity are not typically covered by Medicare. When the FDA approved semaglutide as a way to treat certain cardiovascular risks, however, CMS said Medicare coverage was on the table. 

Immigration attorney Kathleen Campbell Walker explains how can immigration help solve the healthcare staffing shortages.

Immigration barriers prevent solution to healthcare staffing shortages

Kathleen Campbell Walker, JD, immigration practice attorney, and past president of the American Immigration Lawyers Association (AILA), explains the barriers to global physician mobility amid growing shortages.

SCAI calls on interventional cardiologists to tell Washington to reverse physician pay cuts

Congress is considering two bills that would prevent or mitigate the Medicare physician payment cuts that went into effect in January 2024, and the Society for Cardiovascular Angiography and Interventions is urging members write their Congressmen.

The U.S. Food and Drug Administration (FDA) has announced that Inari Medical is recalling its ClotTriever XL catheter for removing blood clots and other blockages from large blood vessels. The news comes after the FDA received several reports of “serious adverse events” due to the device becoming entrapped or blocking arteries in the patient’s lungs. Six deaths and four other patient injuries have been associated with the issue so far.

FDA announces recall of Inari Medical catheter after 6 deaths, 4 injuries

The FDA ruled that this is a Class I recall due to the significant risks for patients. Customers are not required to return the devices, however. Inari Medical has provided updated warnings and recommendations that should be followed. 

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

AISAP, an Israeli healthcare technology company focused on using artificial intelligence (AI) to enhance medical imaging results, has gained U.S. Food and Drug Administration (FDA) clearance for its new point-of-care ultrasound (POCUS) software platform, AISAP Cardio.

FDA clears AI-powered POCUS platform for structural heart disease, heart failure

The cloud-based platform was designed to help even inexperienced users scan and diagnose a majority of common heart issues within minutes without leaving the patient’s side.

AI cardiology heart artificial intelligence deep learning

FDA approves new AI-powered imaging software from Nanox subsidiary

According to Nanox.AI, previously known as Zebra Medical Vision, the updated software helps "bridge the divide between radiology and cardiology."

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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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