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 examine how residual TR after transcatheter tricuspid valve repair impacts survival
Researchers tracked data from more than 600 patients, noting that heart teams may want to reconsider how they classify residual TR after treatment.
Medical device startup gains FDA clearance for new RF guidewire, raises $12.5M
Atraverse Medical, a San Diego-based medical device company founded in 2022, designed the guidewire to give physicians as much freedom as possible while treating heart patients.
FDA grants breakthrough device designation to new TMVR device from 4C Medical
The supra-annular AltaValve System was designed to treat both primary and secondary mitral regurgitation. It is implanted via transseptal access and positioned above the native mitral valve.
FDA announces another new recall involving Abbott’s HeartMate 3 LVADs after 70 injuries, 2 deaths
Abbott issued the new recall after receiving more than 80 reports of blood or air entering the LVAD during implant procedures. Customers can still use these devices, but they are advised to follow specific steps to limit the risk of complications.
World Health Organization urges countries to limit salt intake to reduce risk of CVD, hypertension
The group wants countries to implement population-wide changes that can keep salt intake to a minimum. It estimates that such policies could save up to 900,000 lives in just a few years.

FDA announces recall of nearly 88,000 implantable cardiac devices due to risk of serious injury or death

The recall is related to short circuit protection (SCP) alerts that were causing the devices to send reduced-energy electric shocks. There have been 27 customer complaints about the issue so far.

August 19, 2022

American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification

The new certification, based on recommendations published in Circulation, was developed to signal that a facility offers cardiac surgery and primary PCI at all times.

August 17, 2022

Cardiovascular deaths are on the decline—but there is still a lot of work to do

Three recent NIH-supported studies took a close look at disparities in cardiovascular care.

August 11, 2022

How would the proposed 2023 MPFS impact your cardiology practice? Use this free tool to find out

The American College of Cardiology has developed a helpful calculator that allows cardiologists and practice managers to estimate just how much the proposed 2023 MPFS could impact their practice.

August 11, 2022

Cardiologist-backed bill focused on the heart health of South Asian Americans gains momentum

After successfully making it through the House, the new legislation is now headed to the Senate.

August 1, 2022

Cardiologists, radiologists join American Medical Association to speak out against ACA lawsuit

Yet another lawsuit is taking aim at the Affordable Care Act, and 61 U.S. medical organizations have joined forces to speak out.

July 29, 2022

Noteworthy FDA approvals of the week: Ceiling-mounted CT angiography, AI for brain-adjacent bleeds

Two companies serving medical imagers just had products cleared for marketing in the U.S.

July 28, 2022

Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA

Regulatory Roundup: FDA clears AI-powered Apple Watch competitor, grants breakthrough designation to new heart failure device

Ancora Heart received the FDA’s breakthrough device designation for its AccuCinch Ventricular Restoration System, a new minimally invasive transcatheter device designed for the treatment of heart failure.

July 25, 2022

Around the web

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.

Radiology Business

What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Policy & Regulations

Cardiologists examine how residual TR after transcatheter tricuspid valve repair impacts survival

Medical device startup gains FDA clearance for new RF guidewire, raises $12.5M

FDA grants breakthrough device designation to new TMVR device from 4C Medical

FDA announces another new recall involving Abbott’s HeartMate 3 LVADs after 70 injuries, 2 deaths

World Health Organization urges countries to limit salt intake to reduce risk of CVD, hypertension

Around the web