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. 

The rapid rise of artificial intelligence (AI) has helped cardiologists, radiologists, nurses and other healthcare providers embrace precision medicine in a way that ensures more heart patients are receiving personalized care.

FDA clears AI screening tool for cardiac amyloidosis

Ultromics designed EchoGo Amyloidosis to evaluate routine echocardiogram results for signs of cardiac amyloidosis. It received the FDA's breakthrough device designation back in 2023.

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AI-based ARIA detection software could bring 'renewed hope' for people undergoing Alzheimer's treatment

The software is the first of its kind to achieve the FDA's approval for detecting, measuring and grading ARIA on MRI scans—a task that is critical in managing the disease. 

Video of FDA Commissioner Robert Califf, MD, explaining the need for clinicians to take up fight against health misinformation with grassroots efforts in their communities. #misinformation #FDA #science

FDA commissioner urges clinicians to join fight against medical misinformation

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

MRI accident prompts questions on safety

CMS to make proposed MRI safety codes official

The new code family was created to "capture the physician work involving patients with implanted medical devices that require access to MR diagnostic procedures."

Rad's alleged involvement in peddling date rape drug lands him behind bars

Authorities became suspicious of the doctor after intercepting a package containing around 15 pounds of gamma-butyrolactone, a common date rape drug also known as “liquid ecstasy."

‘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.

HeartLung Technologies, a Houston-based artificial intelligence (AI) company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new software that assesses chest CT scans for signs of coronary artery disease (CAD) and other potentially fatal heart conditions. The newly cleared offering, AutoChamber, was designed with opportunistic heart evaluations in mind.

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. 

Why is the US still dependent on foreign medical isotope production?

The U.S currently does not have any large-scale commercial production of the isotope Mo-99 used for nuclear imaging. It is critical to more 40,000 nuclear imaging exams each day, representing about 80% of all diagnostic molecular imaging procedures.  

Around the web

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.

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.

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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