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.

FDA highlights risks of evaluating blood pressure with unauthorized medical devices
The agency emphasized that many over-the-counter technologies marketed for this purpose have not been properly evaluated.
Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more
Getting healthcare AI to fulfill its destiny—can we call it that now?—will require ‘scenario-based’ consideration of every use case.
Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants
The finding is based on an analysis of nearly 1.4 million office-based imaging claims, conducted by the Harvey L. Neiman Health Policy Institute.
Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services
“It is not an exaggeration to say that the requirement of prior authorization for traditional Medicare services will kill seniors,” says Rep. Mark Pocan, D-Wis.
Referrers frequently failing to recommend patients for key interventional radiology procedure
An analysis of nearly 272,000 uterine fibroid healthcare encounters shows that only about 4% of women underwent uterine fibroid embolization, a minimally invasive IR treatment option.

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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.

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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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.

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.

Policy & Regulations

FDA highlights risks of evaluating blood pressure with unauthorized medical devices

Healthcare AI today: Another angle on AI regulation, move fast but don’t break things, WISeR in the real world, more

Repeat imaging rates higher when scans are interpreted by nurse practitioners, physician assistants

Members of Congress condemn Medicare model targeting ‘wasteful’ interventional radiology services

Referrers frequently failing to recommend patients for key interventional radiology procedure