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.

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
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.

March 20, 2024
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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
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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. 

March 18, 2024
Former managers of a Tampa Florida-based radiology company Advanced Diagnostic Group (ADG) and its employee stock ownership plan (ESOP) retirement benefit manager GreatBanc Trust Co. will pay $19 million to settle a class action lawsuit. The suit alleges they allowed the ESOP’s value to be diverted to managers, directors and their shell companies and away from employee participants. money gavel court lawsuit legal judge judgement

Proposed class action lawsuit accuses radiology practice of failing to protect patient information

Attorneys allege Eastern Radiologists failed to implement the proper protections that would have kept hackers from capturing nearly 890,000 patients’ data. 

March 18, 2024
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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
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