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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Impella Heart Pump Abiomed RECOVER IV RCT cardiogenic shock

FDA warns Abiomed about ‘significant violations’ related to its Impella heart pumps

The agency said Abiomed did not seek the necessary approvals for one Impella-related device and was slow to act on certain safety concerns. 

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Endotronix gains key approval from FDA, shares new heart failure data

The company can now begin the enrollment process for its PROACTIVE-HF 2 clinical trial, which will focus on treating patients with NYHA class II heart failure. 

physician money payments dollars

Mobile imaging provider to pay $85M for false claims stemming from alleged referral scheme

The alleged kickback scheme spanned nine years, with Cardiac Imaging Inc. paying physicians "excessive fees" to oversee PET scans, the DOJ said.

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Costco sued over sharing health data with Meta

Costco is accused of using the Meta Pixel tracker to share sensitive information about its customers with the social media giant.

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Medical societies representing radiology, emergency medicine and anesthesiology blast new NSA guidance

“Our organizations are strongly opposed to this newest guidance, which further broadens the already significant discretion health plans had," RBMA and others wrote Oct. 9. 

Inmate, prison guard stuck to MRI machine at unregulated site

The incident happened at a SimonMed location in Arizona after staff failed to remove a waist shackle from the inmate.

An RSNA attendee undergoes an MRI brain scan on the expo floor using the Hyperfine Swoop head MRI system. It is self-shields with a low field 0.064 T. It uses a standard wall power outlet and can be wheeled through a standard 34-inch wide door frame. It weighs 1,400 pounds. Imaging sequences include T1, T2, FLAIR, and DWI (with ADC map) and its operational controls are all directed on an iPad interface. #RSNA #RSNA22

FDA clears new artificial intelligence capabilities for portable MRI scanner

This is the eighth clearance in the past three years for Hyperfine's Swoop system, company officials said Monday. 

Lab owner confesses to $359M fraud involving COVID tests

A married couple operating a lab in California admit to billing Medicare for unnecessary rapid COVID tests.

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