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. 

An example of an FDA cleared radiology AI algorithm to automatically take a cardiac CT scan and identify, contour and quantify soft plaque in the coronary arteries. The Cleerly software then generates an automated report with images, measurements and a risk assessment for the patient. This type of quantification is too time consuming and complex for human readers to bother with, but AI assisted reports like this may become a new normal over the next decade. Example from Cleerly Imaging at SCCT 2022.

Legal considerations for artificial intelligence in radiology and cardiology

There are now more than 520 FDA-cleared AI algorithms and the majority are for radiology and cardiology, raising the question of who is liable if the AI gets something wrong.

FDA grants passage to autonomous, biology-guided radiotherapy

A therapeutic oncology company has been cleared to market a cancer treatment that that turns a tumor’s own biology into a self-signaling target for radiation therapy.

Brent Savoie, MD, JD, vice chair for radiology informatics, section chief of cardiovascular imaging, Vanderbilt University, explains who will get sued when there is a misdiagnosis due to artificial intelligence (AI).

VIDEO: Who gets sued when radiology AI fails?

Brent Savoie, MD, JD, vice chair for radiology informatics, section chief of cardiovascular imaging, Vanderbilt University, explains who will get sued when there is a misdiagnosis due to artificial intelligence (AI).

Portable orthopedic tomosynthesis cleared for U.S. sales

The FDA has cleared U.K.-based Adaptix to market a 3D X-ray system that, according to the company, images hands, feet and elbows “at a fraction of the radiation dose and per-study cost of traditional CT.”

Tesla-crashing radiologist held without bail

Remember the radiologist who drove himself and his family over a rocky California cliff in an alleged—and fortunately failed—suicide-murder attempt? He’s out of the hospital and in jail.

EU organizes aggressive anti-cancer action around imaging

The executive branch of the European Union has launched a major project to aggregate cancer imaging data from across the continent so it can be readily tapped by healthcare providers, medical schools and industry innovators.

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High hopes still afloat as promising Alzheimer’s drug loses bid for accelerated approval

The FDA has declined to accelerate approval of Eli Lilly’s highly anticipated Alzheimer’s drug, but the reason for the rejection may presage a forthcoming thumbs-up.

ACR to Biden cabinet members: Please help make independent dispute resolution fair and accessible for all stakeholders

The American College of Radiology has worked out a way to protect patients from surprise medical bills for out-of-network services while modifying third-party arbitration so it sensibly serves providers and payers alike.  

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 all-in-one Omni Legend PET/CT scanner is now being manufactured in a new production facility in Waukesha, Wisconsin.