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.

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.

May 16, 2024

Atraverse Medical Hotwire radiofrequency (RF) guidewire. 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.

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.

May 16, 2024

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.

May 15, 2024

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.

May 15, 2024

Salt substitutes are associated with a reduced risk of high blood pressure without increasing the risk of low blood pressure, according to new findings published in the Journal of the American College of Cardiology.[1]

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.

May 15, 2024

Remote ECG access on a smart phone via the Viz.ai Cardio Suite, which enables access to dynamic ECG, echo, MRI, CT images and reports. It also enables automated detection on imaging to alert care teams for STEMI, hypertrophic cardiomyopathy, pulmonary embolism, aortic dissection and abdominal aortic aneurysm, and heart failure.

Cardiology ranked No. 2 among all specialties with 122 FDA-cleared AI models

Only radiology is associated with more FDA-cleared AI algorithms than cardiology, according to new federal data.

May 14, 2024

lex Sandhu, MD, MS, assistant professor of cardiovascular medicine, Stanford University, and cardiologist at the Palo Alto VA. He spoke in the business of cardiology sessions at ACC 2024 and explained how Medicare reimbursements will be moving toward a value based payment model by 2030. #ACC #ACC24 #ACC2024 #CMS #reimbersements #Medicare

How the shift to value-based reimbursements could transform cardiology

"I think we really need our cardiologist community to understand the changes that are happening with value-based payment," one expert tells Cardiovascular Business.

May 13, 2024

New hypertrophic cardiomyopathy guidelines highlight importance of exercise, new drug class

HCM is widely underdiagnosed, but the American College of Cardiology and American Heart Association hope their new guidelines can help cardiologists learn more about the potentially fatal condition and improve patient care.

May 10, 2024

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."