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Blood filtration company fined $5.7M, executive charged, for covering up patient deaths

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.

Tenaya Therapeutics could earn up to $1.1B for new heart disease research

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 now has more than 200 FDA-cleared AI algorithms

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.

FDA clears AI-enabled cardiac MR planning technology from Philips

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 warns public about reprocessed catheter recalls—devices should be destroyed

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

Radiology experts develop practical framework for evaluating AI models before purchasing

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.

American College of Radiology criticizes administration’s push to make higher education more affordable

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."

Two drug suppliers plead guilty in $50M ‘straw purchase’ resale scheme

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.

Report: UnitedHealth under investigation by DOJ for criminal fraud

Citing sources familiar with the matter, the Wall Street Journal reports that UnitedHealth Group is being investigated for criminal fraud, likely stemming from its Medicare Advantage billing practices.

UnitedHealth agrees to $1.8M settlement over robocall complaint

The unwanted spam calls were associated with Optum's home healthcare service. Plaintiffs alleged they received the marketing calls despite opting out and never signing up, in violation of federal consumer protection laws. The company does not admit to wrongdoing.

uAngio AVIVA interventional X-ray system

FDA approves industry's first hands-free interventional X-ray system

Its voice recognition capabilities give providers the ability to maneuver the system and view images in real-time hands-free.

Duke specialists to detail the benefits of treating heart failure with Barostim

Specialists with Duke University Medical System will participate in a free webinar focused on their experience treating heart failure with the implantable Barostim technology from CVRx.

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Health Exec

Blood filtration company fined $5.7M, executive charged, for covering up patient deaths