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.

Ken Rosenfield, MD, Mass General Hospital, explains the impact wider CMS reimbursement for carotid artery stenting will have on patient stroke care and interventional cardiology. CAS

Q&A: Ken Rosenfield explains the impact of new reimbursement coverage for carotid stenting

Ken Rosenfield, MD, helped spearhead the recent Medicare policy change that made carotid stenting procedures available to more patients.

October 20, 2023

Edwards Lifesciences gains CE mark approval for Evoque transcatheter tricuspid valve replacement (TTVR) system

Edwards gains CE mark approval for new tricuspid valve replacement device

The approval represents a significant moment in the treatment of structural heart disease. Edwards will share updated data on the device at TCT 2023 in San Francisco.

October 19, 2023

CMS changes coverage policy for carotid stenting to make it more widely available

A group of interventional cardiologists, neurologists and vascular surgeons successfully petitioned Medicare to change its coverage determination for carotid stenting procedures.

October 18, 2023

Medtronic's Evolut FX TAVR valve, designed with 3 golden markers that improve alignment

Medtronic receives CE mark approval for Evolut FX TAVR system

The self-expanding valve, already approved by the FDA, was designed with three gold markers to boost implanter efficiency, an updated catheter tip and a more flexible delivery system.

October 13, 2023

Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock

FDA warns Abiomed about ‘significant violations’ related to its Impella heart pumps

The agency said Abiomed did not seek the necessary approvals for one Impella-related device and was slow to act on certain safety concerns.

October 12, 2023

Endotronix gains key approval from FDA, shares new heart failure data

The company can now begin the enrollment process for its PROACTIVE-HF 2 clinical trial, which will focus on treating patients with NYHA class II heart failure.

October 11, 2023

Patisiran, marketed under the name Onpattro

FDA chooses not to approve patisiran for treating ATTR cardiomyopathy

The announcement came just weeks after an FDA subcommittee voted in favor of approval.

October 9, 2023

What is CKM syndrome? American Heart Association outlines how to identify and manage a dangerous new condition

The American Heart Association has developed an updated strategy for the prevention and management of cardiovascular disease. A newly defined health condition, cardiovascular-kidney-metabolic syndrome, sits at the center of that strategy.

October 9, 2023

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.

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