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.

American Heart Association ‘enthusiastically’ joins other cardiology groups in push for new, independent medical board

AHA members have voted to throw their full support behind the efforts to establish a new American Board of Cardiovascular Medicine.

November 7, 2023

FDA announces Class I recall of nearly 2,000 catheter kits

Medical facilities and distributors have been advised to immediately discontinue the use of these devices due to a significant labeling issue.

November 7, 2023

Surgeons warn it is too early to recommend a TAVR-first strategy for low-risk patients

The Society of Thoracic Surgeons and European Association for Cardio-Thoracic Surgery say more information is still required before any conclusions can be made about the long-term benefits of TAVR in low-risk patients.

November 6, 2023

CMS increases reimbursement for CVRx’s implantable Barostim device for heart failure

Implanting the Barostim device is now associated with an average payment amount of $45,000, up significantly from the previous average of $29,000.

November 3, 2023

Medicare money payment reimbursement dollar decline george washington

Cardiologists, heart surgeons and imaging experts push for changes that could prevent ‘permanent and unjustifiable Medicare cuts’

More than 100 U.S. medical societies are throwing their support behind a new proposal that could reform out-of-date Medicare policies and help limit future payment cuts.

November 3, 2023

The Evoque transcatheter tricuspid valve replacement (TTVR) system for tricuspid regurgitation from Edwards Lifesciences

More good news for Edwards: ‘Landmark study’ confirms new TTVR system reduces tricuspid regurgitation, improves symptoms

New data presented at TCT 2023 suggest the Evoque tricuspid valve replacement system could make a significant impact on the lives of patients with severe TR.

October 27, 2023

Late-breaking clinical trials at TCT 2023 could lead to FDA approvals for Abbott, Boston Scientific

Will a coronary drug-coated balloon finally gain full approval from the FDA? New data presented at TCT 2023 seems to suggest it just might happen.

October 26, 2023

Medtronic extravascular ICD Aurora EV-ICD MRI SureScan

FDA approves Medtronic’s extravascular ICD for abnormal heart rhythms

The Aurora EV-ICD MRI SureScan is similar in size and shape to traditional ICDs, but it is implanted outside of the patient’s heart and veins.

October 24, 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