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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SmartSpeed Precision DL recon software earns FDA clearance

10-second brain MRI scans possible with newly FDA-cleared deep learning reconstruction software

The artificial intelligence-enabled software offers accelerated acquisition times, improved image resolution and one-click workflows for technologists.

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'Technical issue' prevents providers from receiving alerts on actionable imaging findings for 3 years

The system uses color coded flags to alert general practitioners that a patient's imaging report contains "serious or unexpected” findings.

Johnson & Johnson MedTech Automated Impella Controller

FDA shares warning after Johnson & Johnson heart pump controllers linked to 3 deaths

Johnson & Johnson MedTech has received reports of its Automated Impella Controller failing to connect properly with Impella heart pumps. If this happens, the FDA warned, it may put patients at risk.

COVID-19 vaccine vaccination myocarditis heart damage inflammation RSNA imaging radiology cardiology

Vaccines—for the flu, COVID-19 and other infections—are a ‘foundational pillar’ of heart protection

Staying vaccinated as recommended by doctors can help patients limit their risk of adverse cardiovascular events, according to a new consensus statement published in European Heart Journal.

Congress Senate Washington D.C. DC

Senate bounces spending bill back to House with 2.5% Medicare rad pay fix

In addition, there are no restrictions on pass-through entity taxes (PTET), which “benefits independent physician practices,” one expert notes. 

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Medicare cost-cutting initiative targets ‘wasteful, inappropriate’ interventional radiology services

IRs criticized the CMS proposal, believing it could lead to excess morbidity and mortality in Medicare. 

Medicare Money dollar payment reimbursement

103K Medicare beneficiaries issued new IDs after ‘data incident’ at CMS

The Centers for Medicare & Medicaid Services said “malicious actors” created fake accounts for Medicare beneficiaries through the agency’s patient portal, using stolen data from an unknown source. The incident is being investigated. 

the words "FDA recall" on a board

FDA announces recall of Baxter infusion pumps with mismatched software

Spectrum V8 and V6 infusion pumps may have accidentally had their software switched, which could result in underinfusion or a fluid overload. While no injuries have been reported, for safety the affected pumps need to be removed from where they are used and sold. 

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