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 classifies Vyaire recall as ‘most serious’

The FDA has issued a Class I recall for Vyaire Medical respiratory support devices, saying use of older, defective devices could result in injury or death.

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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.

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Nearly 15% of claims submitted to private payers are initially denied

Private payers eventually overturned more than half of denials, with the claims paid, but only after “multiple, costly rounds of provider appeals.” 

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.

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

FDA clears AI-enhanced 3D heart models generated from MR and CT images

The inHeart models significantly reduce cardiac ablation surgery times.

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. 

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Change Healthcare reaches ‘important’ step in resumption of services after cyberattack

To aid in this transition, Change owner UnitedHealth Group has advanced more than $2 billion in payments through multiple initiatives. 

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