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 clears GE HealthCare’s AI solution for enhancing PET/CT image quality

Precision DL was engineered using a deep neural network, trained with thousands of images, the Chicago-based company said May 30. 

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Cardiology groups issue statement on bullying, harassment and discrimination within the specialty

Bullying and other inappropriate workplace behaviors have been linked to an increased risk of errors and worse patient outcomes. 

Sam Jones, MD, explains why CMS reduced payments for EP ablation and how it will negatively impact electrophysiology. #HRS #HRS2023 #EPeeps #EPlab #Medicare

Making sense of the huge Medicare reimbursement cuts in electrophysiology

Samuel Jones, MD, examines the large reimbursement reductions in cardiac ablations and what the impact might be on access to care in EP labs.

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Imaging advocacy group slams ‘extremely restrictive’ Medicare coverage determination

A Medicare Administrative Contractor is wrongly rejecting coverage of PET imaging in cases of infection/inflammation, SNMMI reported recently. 

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FDA approves new PSMA-targeted PET imaging agent for prostate cancer

Blue Earth Diagnostics said this is the first and only PSMA-targeted imaging agent developed with its proprietary radiohybrid technology.

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Integra poised to take $60 million hit following voluntary recall of devices manufactured at Boston facility

Production of Integra’s SurgiMend, PriMatrix, Revize and TissueMend products has been temporarily halted due to the recalls, although the company said it has not received any customer complaints. 

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FDA approval of several impactful drugs could be delayed if US defaults on debt

The FDA’s process of reviewing and approving drugs and devices could be put on hold, if lawmakers fail to reach a deal related to the debt ceiling.

11 leading cardiology societies collaborate on new AUC for chronic coronary disease

The new AUC document, which examines the treatment of both symptomatic and asymptomatic patients, was published in full in the Journal of the American College of Cardiology.

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