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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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.

CMS may double Medicare payments for cardiac CT

The agency is gathering feedback on a proposal to double the amount hospitals are paid for coronary computed tomography angiography, with the comment period ending Sept. 9.

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Around the web

Cardiovascular Business
A closer look at how FDA's flurpiridaz approval will impact nuclear cardiology

The newly approved PET radiotracer is expected to improve patient care significantly. “We have been able to reach the pinnacle of myocardial perfusion imaging with flurpiridaz," one expert said.

Cardiovascular Business
'This could be a paradigm shift': How PET with newly approved flurpiridaz compares to SPECT

GE HealthCare's flurpiridaz, the PET radiotracer that recently received FDA approval, offers several key benefits over SPECT. Jamshid Maddahi, MD, discussed the details in an exclusive interview. 

Cardiovascular Business
Ultrafast myocardial contrast echocardiography shows early potential to evaluate CAD

Ultrafast MCE could go on to become a go-to treatment option for obstructive coronary artery disease, according to the authors of a new first-in-human clinical study.

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