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. 

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
Boston Scientific’s Agent Drug-Coated Balloon (DCB), which delivers a therapeutic dose of the anti-proliferative drug paclitaxel to the patient’s scar tissue to prevent ISR from recurring, gained FDA approval on March 1..

Cardiologists share historic research that led to FDA’s long-awaited approval of coronary DCB

When Boston Scientific’s coronary DCB gained approval in the United States, it was a moment the country's cardiologists had been looking forward to for years. The cardiologists who researched the device have now detailed their findings, highlighting the "unmet need" this technology is addressing. 

March 14, 2024
Elderly patient doctor. Despite an expanded indication from the FDA and lower prices, patient access to these cholesterol-lowering medications remains a significant issue.

Cognitive impairment among heart failure patients: How cardiologists can help

The Heart Failure Society of America shared a new scientific statement about this topic, noting that many patients may require additional help.

March 13, 2024
Recall | Product recall

Abbott recalls device for tracking LVAD data after 8 injuries

This is a Class I recall, which means using the device “may cause serious injuries or death.” However, the FDA emphasized that this is a correction and not a product removal.

March 11, 2024
Medicare data stethoscope healthcare trends graphs finance financials

ACC, SCAI say new funding bill did not do enough to limit Medicare reimbursement cuts to cardiology services

President Joe Biden signed a funding bill worth $460 billion on March 9, but it only included partial relief for cardiologists, cardiac surgeons and other cardiology professionals. 

March 11, 2024

Around the web

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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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