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.

doctor in handcuffs after being arrested

Cardiologist charged with fraud for allegedly altering patient records, billing for unnecessary procedures

The doctor allegedly targeted some patients more than ten times, treating them again and again with procedures that were not medically necessary.

December 15, 2023

Newsweek ranked the 50 best heart hospitals in the world

Deaths from CVD are on the rise, cardiologists warn—high blood pressure, obesity remain 2 primary culprits

Cardiovascular disease remains one of the leading causes of mortality in the world, responsible for nearly 20 million deaths in 2022 alone.

December 11, 2023

FDA announces recall of Cardiohelp ECMO emergency drives due to serious risks

If the emergency drive is needed during treatment, it could fail to work, putting patients at risk of ischemia, hypoxia, stroke or death.

December 8, 2023

older patient with a doctor at their house

Learning more about AFib: 19 important topics for cardiologists, other heart specialists to investigate

New AFib recommendations from the American College of Cardiology and American Heart Association covered significant ground—but there is still much more to learn, experts explained.

December 4, 2023

BiVACOR Total Artificial Heart. BiVACOR, an international medical device company with headquarters in the United States and Australia, has received approval from the U.S. Food and Drug Administration (FDA) to kick off an early feasibility study (EFS) for its total artificial heart (TAH) technology.

FDA approves early feasibility study for total artificial heart technology

The device is intended to be a bridge for heart failure patients waiting to receive a full heart transplant.

December 1, 2023

FDA announces recall of infusion sets due to defect that puts diabetes patients at risk

The FDA considers this a Class I recall, which means using the impacted devices “may cause serious injuries or death.” One patient injury has been reported at this time.

November 27, 2023

Medtronic's PulseSelect Pulsed Field Ablation (PFA) System

Medtronic gains 2 key approvals for its ablation portfolio

The company had good news to share about its highly anticipated PFA offering.

November 21, 2023

Arineta Cardio Imaging, a healthcare company based in Israel, gained clearance from the U.S. Food and Drug Administration (FDA) for the deep learning image reconstruction (DLIR) technology used in its SpotLight cardiovascular CT scanners. Arineta Cardio Imaging cardiovascular CT scanners AI.

FDA clears AI-powered image reconstruction technology for cardiac CT scanners

The new technology, trained using more than 3 billion data points, was designed to reduce image noise and improve the overall quality of CT scans.

November 20, 2023

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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