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.

Cardiologists reflect on developing primary PCI in face of criticism and pushback
SCAI celebrated cardiologists William W. O'Neill, MD, and Cindy L. Grines, MD, for the important roles they played in the development of primary PCI. “It was challenging,” Grines explained. “We had the pharmaceutical industry that was anti-primary angioplasty and we had a lot of our own colleagues that were anti-primary angioplasty."
FDA clears AI screening tool for cardiac amyloidosis
Ultromics designed EchoGo Amyloidosis to evaluate routine echocardiogram results for signs of cardiac amyloidosis. It received the FDA's breakthrough device designation back in 2023.
Surgical devices recalled after 17 serious injuries—FDA warns of possible shortage
Vessel harvesting devices from Getinge have been recalled due to pieces breaking off during medical procedures. In some cases, surgeons were unable to retrieve the broken pieces.
Eko Health’s AI platform for digital stethoscopes granted new CPT code
The Sensora platform, which includes multiple FDA-approved algorithms, has a new Category III CPT code.
Cardiologist demand is on the rise—can hospitals keep up?
Demand for inpatient and outpatient cardiology services is expected to increase significantly in the next decade, putting hospitals and health systems in a position where they need to plan ahead or risk falling behind.

Coronary IVL now recommended at all cath labs, even those without surgical backup

The latest SCAI guidance on the safety of PCI procedures included a key change that could expand coronary IVL utilization throughout the United States.

February 1, 2023

CardiacSense, an Israel-based healthcare technology company, gained FDA clearance for its CSF-3 medical watch

Regulatory Roundup: FDA clears new medical watch, considers empagliflozin for CKD and much more

Our monthly review of FDA-related news items in the world of cardiology includes updates from CardiacSense, MedAlliance, Lupin, Realize Medical and Eli Lilly and Company.

January 31, 2023

Interventional cardiologists can safely perform PCI without on-site surgical backup

The finding comes from a new expert consensus statement published by the Society for Cardiovascular Angiography and Interventions. Several industry societies, including the ACC and AHA, have endorsed the document.

January 30, 2023

FDA issues new recall for circulatory support system after software update

The device was first recalled in 2022, but a new software update has now been released that addresses the issue. The FDA wanted a new recall to be issued to ensure all customers went through with the update.

January 30, 2023

FDA announces new IABP recall after 4 serious injuries, 1 death

The new recall includes nearly 4,500 devices. There have been 134 incidents so far, including 5 adverse events.

January 25, 2023

FDA approves new medication for type 2 diabetes

The newly approved SGLT2 inhibitor, bexagliflozin, is marketed under the name Brenzavvy. It is not recommended for patients with type 1 diabetes.

January 23, 2023

Abbott has gained U.S. Food and Drug Administration (FDA) approval for its Navitor transcatheter aortic valve replacement (TAVR) system, the company’s new self-expanding valve for high-risk patients with severe symptomatic aortic stenosis.

Abbott receives FDA approval for new self-expanding TAVR system

The device, which gained CE mark approval in Europe in May 2021, features a new-look fabric cuff designed to keep the risk of paravalvular leak (PVL) at a minimum.

January 17, 2023

Medicare update designed to help heart failure patients may have the opposite effect

When Medicare made it easier for heart failure patients to receive a LVAD at a hospital that does not perform heart transplants, the change was intended to improve patient access. It turns out, however, that the policy shift could be linked to an unintended consequence.

January 12, 2023

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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.

Policy & Regulations

Cardiologists reflect on developing primary PCI in face of criticism and pushback

FDA clears AI screening tool for cardiac amyloidosis

Surgical devices recalled after 17 serious injuries—FDA warns of possible shortage

Eko Health’s AI platform for digital stethoscopes granted new CPT code

Cardiologist demand is on the rise—can hospitals keep up?

Around the web