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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.

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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 issues recall of imaging systems
FDA shares details about reprocessed catheter recall

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.

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. 

money education graduate cap
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." 

handcuffs arrested arrest jail
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.

Hospital executive job market
Is the job market for health execs about to undergo a shakeout?

Among healthcare organizations sweating the possible passage of the “One Big Beautiful Bill,” few have more to worry about than nonprofit hospitals and health systems that compete with privately held or publicly traded rivals for executive talent.

AI detects incidental breast lesions on routine CT scans
AI detects twice as many incidental lesions as radiologists

Prior research has suggested that these incidental lesions turn out to be cancerous in up to 70% of cases, making their timely detection critical. 

Tom Price, MD, an orthopedic surgeon and former secretary of Health and Human Services (HHS) during the first Trump administration, says misinformation and growing distrust of healthcare workers and institutions is negatively impacting healthcare and more needs to be done to combat it.
Former HHS secretary says healthcare needs to fight back against medical misinformation

Tom Price, MD, an orthopedic surgeon and secretary of Health and Human Services (HHS) during the first Trump administration, says misinformation and growing distrust of healthcare workers and institutions is negatively impacting healthcare and more needs to be done to combat it. 

Foldax Tria mitral valve
‘A compelling alternative’: Polymer heart valve receives first commercial approval of its kind

A new surgical mitral valve from Foldax will now be commercially available in India. The valve is built using LifePolymer, a proprietary material that does not include animal tissue.

Around the web

Health Exec
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.

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