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 recall medical device recall product recall

FDA announces Class I recall of patches used for heart surgery

There is a risk of certain pericardial patches not being as strong or durable as needed. Customers are urged to identify, quarantine and replace these devices.

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AI news & views in brief: State regulation ban or none, AI in healthcare advertising, more

Will there or won’t there be a federal moratorium on state-level regulation of AI? That’s only one question healthcare stakeholders are asking as 2025’s time begins running out.

CVS Health announces $10.6B acquisition of Oak Street Health

CVS agrees to pay $38M to resolve insulin over-distribution allegations, DOJ says

Authorities allege the pharmacy chain gave patients more insulin than prescribed and then billed Medicare and Medicaid for the full amounts. This allegedly occurred for more than a decade. 

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The BI-RADS 2025 Manual is now live—here are a few of its key updates

During an education session at RSNA 2025, several experts who contributed to the manual spoke on what has changed and how these revisions will affect providers.

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Damaged Alaris infusion pumps linked to two serious injuries as FDA updates safety instructions

The infusion system modules can malfunction if dropped or jarred without the user noticing. Manufacturer Becton Dickinson is asking owners to inspect the devices to ensure they are safe to use.

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Radiologists urge specialty to ‘speak up’ on reimbursement-related issues

Three radiologists presented on hot topics in imaging economics Sunday during the opening day of RSNA 2025 in Chicago. 

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FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw

All models and lot numbers of the units are subject to the recall. The security vulnerability could allow an unauthorized person to access and control the pumps, posing a serious health risk to patients.

The Society of Cardiovascular Computed Tomography (SCCT) is seeing major progress in its long-running push to secure broad reimbursement for artificial intelligence (AI)-enabled coronary CT angiography (CCTA) plaque analysis. According to Roosha Parikh, MD, FACC, FSCCT, associate director of Cardiac CT at St. Francis Heart Hospital, Long Island, New York, and a member of the SCCT Health Policy and Practice Committee, both Medicare and a growing number of private insurers are now covering the technology.

Reimbursement for AI-based plaque assessments is improving

A growing number of private insurers are now covering these advanced technologies. Roosha Parikh, MD, told Cardiovascular Business that the hard work of SCCT and other groups has helped make this happen.