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The U.S. Department of Justice said ExThera cooperated with the investigation into a failure to file adverse event notices with the Food and Drug Administration after two cancer patients who used its blood filtration systems in Antigua died shortly after returning home. The California-based company’s former chief regulatory officer has agreed to plead guilty and could serve prison time.

heart doctor cardiologist

Tenaya Therapeutics and Alnylam Pharmaceuticals have agreed to collaborate on identifying potential new gene therapies for the treatment of cardiovascular disease. Tenaya will receive an upfront payment of $10 million, but stands to earn much more.

Ligence Heart is a recently FDA cleared AI that fully automates analyses, measurements and reporting for transthoracic echo.

Cardiology is No. 2 behind radiology when it comes to FDA-cleared AI algorithms. Neurology, meanwhile, is a distant No. 3. 

Philips has secured U.S. Food and Drug Administration (FDA) clearance for SmartHeart, the company’s new artificial intelligence (AI)-powered planning technology for cardiac MR (CMR) exams.

The new SmartHeart technology automates 14 cardiac views in less than 30 seconds. It was designed to increase productivity and bring more consistency to cardiology and radiology departments.

FDA issues recall of imaging systems

Back in February, the FDA expanded a recall of several reprocessed EP and ultrasound catheters due to a risk of contamination. The agency is now sharing additional information with the public.

Stanford and Rad Partners recently developed a structured, pre-deployment method for assessing radiology AI models, detailing their work in the American Journal of Roentgenology. 

money education graduate cap

In January, the Department of Education released a proposed rule seeking to simplify federal student loan repayment, including "commonsense loan caps" and "streamlining repayment options." 

handcuffs arrested arrest jail

The two men, Frank Incognito, 46, and Stephen Corba, 50, conspired with doctors in a scheme involving the fraudulent purchase of critical cancer and macular degeneration drugs, which were then diverted and resold for profit. The U.S. Department of Justice said the unlawful pact lasted seven years.

Medicare

Momentum is building for the Medicare Patient Access and Practice Stabilization Act, the AMA notes, with 99 bipartisan co-sponsors in the House. 

congress money medicare washington DC senate house

Failing to fund these functions, advocates contend, will result in challenges that could potentially halt progress in imaging industry innovation. 

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Only about 9% of images examined presented a “realistic view of a radiologist’s job," according to new research out of Belgium. 

Christine B. Chung, MD

Also, AI vendor Lunit hires a new CEO for subsidiary Volpara, Vanderbilt picks a vice chair of community radiology, and Sirona Medical selects its next chief. 

Around the web

The U.S. Department of Justice said ExThera cooperated with the investigation into a failure to file adverse event notices with the Food and Drug Administration after two cancer patients who used its blood filtration systems in Antigua died shortly after returning home. The California-based company’s former chief regulatory officer has agreed to plead guilty and could serve prison time.