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.

Medtronic receives updated FDA approval for redo TAVR
The company also launched a new clinical trial designed to follow redo TAVR patients who present with symptomatic bioprosthetic valve failure for up to five years.
CDC director, chief medical officer ousted as RFK shakes up agency
CDC Director Susan Monarez, PhD, was less than a month into her role, having been confirmed by the U.S. Senate on July 30. Her lawyers said the staffing shakeup was a result of HHS Secretary Robert F. Kennedy Jr. “weaponizing public health for political gain.”
Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS
Radiologists and other physicians recently wrote to Administrator Mehmet Oz, MD, asking for changes related to contrast-enhanced ultrasound.
FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death
This latest alert was put in place after Johnson & Johnson MedTech learned that some of its Automated Impella Controllers were built to the wrong specifications, impacting their ability to function. Affected devices should not be used going forward.
Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval
Gadoquatrane is now set to go through the regulatory review process on its trek to earning full FDA approval.

Dispute between Johns Hopkins and UnitedHealthcare pushes patients out-of-network

The two said they’ve been negotiating terms for eight months. Sticking points include denied claims and coverage disputes, with both the insurer and health system pointing fingers.

FDA announces recall of Boston Scientific interventional radiology devices, citing risk of serious injury or death

Its alert pertains to over 26K carotid artery stents, used by interventional neuroradiologists, vascular surgeons and other docs to prevent strokes.

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Healthcare AI today: $81M acquisition, Illinois says no to AI therapy, AI glucose cleared, more

FDA clears AI-powered glucose monitoring app. The clearance marks a first for an over-the-counter tool in this category.

Data policy research: AI hesitancy remains real, and value-based care models are still an uncertainty

Tech vendor Reveleer and policy analytics firm Mathematica released their 2025 State of Technology in Value-Based Care report, the findings of which show that AI adoption in healthcare is widespread—but integration is spotty.

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AI-enabled devices lacking validation data prior to FDA clearance more likely to be recalled

FDA 510(k) clearance does not require that AI devices are subject to prospective human studies prior to approval.

The Abbott Esprit BTK everolimus-eluting biosorbable scaffold system for below the knee peripheral artery disease on display at TCT 2024. Photo by Dave FornellTCTn 2024 DF

Abbott’s dissolving stent picks up a key approval

It's another big victory for Abbott's bioresorbable stent for BTK PAD.

FDA announces new recall of self-expanding stents due to risk of ‘serious harm’

The Class I recall includes more than 26,000 vascular stents from Boston Scientific. These devices have been linked to a risk of potential resistance when the stent delivery system is being withdrawn.

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Other specialties join radiology in support of bill to boost CT imaging funding

Societies representing chest physicians, orthopedic foot and ankle specialists, thoracic and plastic surgeons, and gynecologic oncologists are joining ACR in the effort.

Policy & Regulations

Medtronic receives updated FDA approval for redo TAVR

CDC director, chief medical officer ousted as RFK shakes up agency

Under-reimbursement keeping radiologists from using key imaging modality, docs warn CMS

FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

Lowest dose gadolinium-based contrast agent to date inches closer to FDA approval