Policy & Regulations

Policy & Regulations

Policy & Regulations

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. 

BiVACOR Total Artificial Heart. BiVACOR, an international medical device company with headquarters in the United States and Australia, has received approval from the U.S. Food and Drug Administration (FDA) to kick off an early feasibility study (EFS) for its total artificial heart (TAH) technology.

The device is intended to be a bridge for heart failure patients waiting to receive a full heart transplant.

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After an investigation by journalists, unregulated SimonMed locations in Arizona must now obtain a license.

Cardiologist heart

Cardiologists, electrophysiologists, surgeons and patient representatives all worked together on the updated guidelines, which were published in both the Journal of the American College of Cardiology and Circulation.

jury court verdict juror lawsuit trial

Neurosurgeon Payam Toobian, MD, oversaw a scam in which two physicians would receive gift cards and cash in exchange for referrals to his imaging center.

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Under terms of the deal, lender Stonepeak will swap some $470 million in debt for ownership in the reorganized business.

Diversity

During remarks Tuesday, radiologist Reed Omary, MD, accused healthcare institutions of “DEI washing."

the words "FDA recall" on a board

The FDA considers this a Class I recall, which means using the impacted devices “may cause serious injuries or death.” One patient injury has been reported at this time. 

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GE said the product also allows radiologists to share expertise, best practices and “in-the-moment” advice with other members of the care team. 

Siemens Healthineers Biograph Vision.X

The Biograph Vision.X is able to deliver an estimated 20% performance improvement, bolstering throughput while reducing radiotracer costs. 

The American College of Radiology and 120 other healthcare organizations recently sent a letter to leaders of the House and Senate, asking them to fix the “flawed” Medicare payment system.

Bob Still RBMA

The RBMA board has agreed to form an Executive Director Search Committee, chaired by Past President Mark Kalmar.

Medtronic's PulseSelect Pulsed Field Ablation (PFA) System

The company had good news to share about its highly anticipated PFA offering.

Around the web

MyBreastAI integrates three AI applications designed to read mammograms and measure breast density.

The device is intended to be a bridge for heart failure patients waiting to receive a full heart transplant.

After an investigation by journalists, unregulated SimonMed locations in Arizona must now obtain a license.