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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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.

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.

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. 

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. 

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. 

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.

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. 

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.

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Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

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.

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