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. 

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Biosense Webster gained CE mark approval for its Varipulse pulsed field ablation (PFA) system in Europe

Biosense Webster takes key step toward FDA approval for Varipulse PFA system

The company already received CE mark approval for its new PFA offering and hopes it will soon be approved for sale in the United States.

March 25, 2024
Medicare money payment

Medicare will now cover weight loss drug semaglutide if taken for heart benefits

The news represents a meaningful policy shift for CMS. In the past, Medicare prescription drug plans have not covered medications designed to help patients lose weight.

March 22, 2024
FDA grants new Elixir Medical Dynamx implant for BTK arterial disease its breakthrough device designation

FDA grants new implant for BTK arterial disease its breakthrough device designation

Elixir Medical's DynamX BTK System is an implantable device that supports BTK vessels after PCI or other interventions.

March 21, 2024
The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling its instructions for certain Impella left-sided blood pumps due to significant safety concerns. New and revised instructions for use (IFU) have been sent to all affected customers.

FDA announces new recall impacting more than 66,000 Impella heart pumps after 49 deaths

More than 100 patients have been seriously injured as a result of a significant safety concern. The Impella devices can still be used, according to the recall, if customers refer to Abiomed's new and revised instructions for use.

March 21, 2024
approved approval

FDA approves new hypertension drug months after Idorsia reacquired rights for $343M

Aprocitentan, sold under the brand name Tryvio, is approved for patients with high blood pressure who are already taking other antihypertensive drugs. 

March 20, 2024
physician money payments dollars

Doctors form new coalition focused on reducing private equity’s role in cardiology, other healthcare specialties

More than 5,000 U.S. physicians joined forces to launch the new group. They say they are focused on limiting private equity's involvement and influence in healthcare. 

March 18, 2024
Breast arterial calcifications (BACs) identified on screening mammograms may help identify women who face a heightened risk of developing cardiovascular disease (CVD), according to a new analysis published in Clinical Imaging.

Incidental breast calcifications on mammograms linked to much higher risk of cardiovascular disease

These findings may say a lot more about a patient's long-term health than clinicians realized. 

March 18, 2024
Biotronik has received the FDA’s breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold (BTK RMS) for patients with chronic limb-threatening ischemia (CLTI).

FDA grants new resorbable scaffold for CLTI its breakthrough device designation

Biotronik's Freesolve technology, which gained CE mark approval in February, is designed to maximize blood flow and minimize the post-implantation risks of stent thrombosis and target lesion revascularization.

March 18, 2024
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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."

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