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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'Game changer' prostate imaging agent granted FDA's Fast Track designation

The PET agent was developed for men with PSMA-positive lesions who have suspected metastasis and are candidates for initial definitive therapy.

AISAP, an Israeli healthcare technology company focused on using artificial intelligence (AI) to enhance medical imaging results, has gained U.S. Food and Drug Administration (FDA) clearance for its new point-of-care ultrasound (POCUS) software platform, AISAP Cardio.

FDA clears AI-powered POCUS platform for structural heart disease, heart failure

The cloud-based platform was designed to help even inexperienced users scan and diagnose a majority of common heart issues within minutes without leaving the patient’s side.

AI cardiology heart artificial intelligence deep learning

FDA approves new AI-powered imaging software from Nanox subsidiary

According to Nanox.AI, previously known as Zebra Medical Vision, the updated software helps "bridge the divide between radiology and cardiology."

Radiologist arrested for alleged lewd acts that were caught on camera

This isn't the doctor's first run in with the law. In 2019, he was arrested for his alleged involvement with a prostitution ring, though those charges were eventually dropped.

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Siemens Healthineers' new AI-enabled cardiovascular ultrasound system granted FDA clearance

The system integrates a slew of AI powered imaging features that have been trained on more than 2 billion annotated images. 

Siemens Healthineers has gained U.S. Food and Drug Administration (FDA) clearance for Acuson Origin, its new cardiovascular ultrasound system featuring advanced artificial intelligence (AI) capabilities. The Acuson Origin represents a significant update from the prior Siemens Healthineers cardiovascular ultrasound system, the Acuson SC2000.

Siemens Healthineers gains FDA clearance for new AI-powered cardiovascular ultrasound system

The Acuson Origin system includes advanced AI algorithms designed to assist users with the treatment of diagnostic, structural heart, vascular, electrophysiological and pediatric patients. It also comes packaged with a new 4D ICE catheter capable of multiplanar reconstruction imaging with or without the use of an electrocardiogram.

Dana Smetherman, MD, ACR CEO, explains AUC may be better than prior authorizations.

ACR CEO discusses solution to fight burdensome prior authorizations in medical imaging

Dana Smetherman, MD, MBA, outlines a possible remedy for the growing number of these roadblocks in the specialty. 

artificial intelligence

FDA adds dozens of AI-enabled radiology applications to list of clearances

Around two-thirds of all approved artificial intelligence-powered clinical devices are catered to radiology settings.

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Around the web

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Cardiovascular Business
FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

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