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.

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries
Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August.
AI for opportunistic osteoporosis screening inks FDA clearance
The tool analyzes routine hip and pelvis X-rays for signs of low bone mineral density.
Radiology groups voice ‘enthusiastic support’ for proposal to add 14,000 more Medicare-funded residency slots
The Society of Interventional Radiology and American College of Radiology are thanking lawmakers for reintroducing the Resident Physician Shortage Reduction Act.
Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.
Why all heart patients should be vaccinated against the flu, COVID-19, RSV
The American College of Cardiology has shared new recommendations highlighting the protective benefits of a variety of vaccines. The new guidance also examines how to speak with patients who are hesitant to be vaccinated.

Radiology Business Management Association Executive Director Bob Still to retire

The RBMA board has agreed to form an Executive Director Search Committee, chaired by Past President Mark Kalmar.

Medtronic's PulseSelect Pulse Field Ablation (PFA) System

Medtronic gains 2 key approvals for its ablation portfolio

The company had good news to share about its highly anticipated PFA offering.

money gavel court lawsuit legal judge judgement

Hospital fails to dodge $10M malpractice verdict after attempting to pin payment on radiologist

A nurse punctured the 68-year-old patient's lung with a feeding tube in 2018, and radiologist Louis Jacobs, MD, subsequently failed to spot the injury on X-ray.

American College of Radiology initiative seeks to improve transparency among AI vendors

The ACR Data Science Institute’s “AI Central” allows physicians to select algorithms that have been vetted for performance.

FDA clears AI-powered brain MRI software from French firm Pixyl

The product aims to reduce radiologists’ read times while bolstering the detection of certain neurological disorders.

Arineta Cardio Imaging cardiovascular CT scanners AI

FDA clears AI-powered image reconstruction technology for cardiac CT scanners

The new technology, trained using more than 3 billion data points, was designed to reduce image noise and improve the overall quality of CT scans.

Medtronic Symplicity Spyral renal denervation

FDA approves another renal denervation system for hypertension

This is the second time in a matter of weeks the FDA has approved an RDN system for uncontrolled hypertension. The SCAI issued a statement about this trend, calling it a “game-changer for both interventional cardiology and the treatment of hypertension."

CVD deaths have increased dramatically, undoing years of progress

The COVID-19 pandemic undid years and years of progress in terms of preventing CVD-related deaths. What can be done to help reverse this trend once and for all?

Policy & Regulations

Update: FDA confirms recalls for defibrillation leads after nearly 400 injuries

AI for opportunistic osteoporosis screening inks FDA clearance

Radiology groups voice ‘enthusiastic support’ for proposal to add 14,000 more Medicare-funded residency slots

Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately

Why all heart patients should be vaccinated against the flu, COVID-19, RSV