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.

FDA approves acoramidis, BridgeBio’s new ATTR-CM drug
Acoramidis, a selective transthyretin stabilizer being sold under the brand name Attruby, is now the second ATTR-CM medication to gain FDA approval.
Medtronic receives key FDA clearance, launches new diabetes system
Medtronic designed its new Smart MDI system to provide real-time insights to users on multiple daily injection therapy.
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.

Medtronic relaunches Harmony TPV system after 2022 recall

The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States.

February 23, 2023

New ACC/AHA/SCAI guidance highlights training requirements for interventional cardiologists

The document, which was designed to help guide both interventional cardiology trainees and program directors, was also endorsed by several other industry societies.

February 22, 2023

Medtronic EV ICD clinical trial safety endpoints ESC Congress 2022

Medtronic’s new extravascular ICD gains key approval

Unlike other ICDs, the lead for this new-look device is placed under the patient's breastbone, outside of their heart and veins.

February 17, 2023

AHA President Michelle Albert explains what can be done to boost healthcare equity and diversity in cardiology.

AHA President Michelle Albert on addressing health equity issues in cardiology

American Heart Association President Michelle Albert, MD, talked to us about about how to address health inequities in cardiology departments.

February 16, 2023

ACC urges all interventional cardiologists to use intravascular imaging during PCI

New recommendations from the American College of Cardiology detail how intravascular imaging can help clinicians before, during and after PCI procedures.

February 16, 2023

Florida cardiology practice, 10 cardiologists pay $2M to settle fraud allegations

The practice and many of its cardiologists allegedly submitted false claims to Medicare, Medicaid, TRICARE and the Federal Employee Health Benefits Program.

February 14, 2023

FDA calls out weight loss pills for ‘hidden’ ingredient that puts health of heart patients at risk

The agency’s own analysis confirmed that these capsules contain sibutramine, which was removed from the market back in 2010 due to safety concerns

February 10, 2023

DiA Imaging Analysis, an Israel-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) clearance for LVivo IQS, a new software solution designed to help users acquire high-quality echocardiography images.

FDA clears new AI-powered cardiac imaging solution

The newly approved software uses artificial intelligence to provide users with real-time feedback related to image quality.

February 6, 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

FDA approves acoramidis, BridgeBio’s new ATTR-CM drug

Medtronic receives key FDA clearance, launches new diabetes system

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

Around the web