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.

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

While a vast majority of heart transplants in the United States are successful, unplanned hospitalizations after the procedures are still incredibly common. Top 10 reasons for readmission after heart transplant.

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

Barostim Neo 2 CVRx heart failure nerve stimulator on display at HRS 2023. Photo by Dave Fornell

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. 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.

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. The Evoque is the first transcatheter tricuspid valve approved by the FDA. It is the first TTVR cleared in the U.S.

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

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