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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 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.

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.

Heart failure biomarker identifies long-term risk in T-TEER patients

NT-proBNP measurements are often used to diagnose and manage heart failure. According to a new study of more than 2,000 patients, they can also provide value to cardiologists performing T-TEER.

Society of Interventional Radiology offers new guidance for treating chronic pelvic pain

The new guidelines focus on pelvic venous disorders, which can cause a wide array of painful symptoms.

doctor patient elderly check up hospital

Heart patients unsure about GLP-1 drugs? A physician’s advice is often the best medicine

When patients fear that GLP-1 drugs are “too new” to be trusted, cardiologists can make a world of difference by closely listening and then explaining how they work.

Radiology societies fight Medicare Administrative Contractor’s proposed coverage restriction

National Government Services is seeking to limit the use of thermal destruction of the intraosseous basivertebral nerve, aka the Intracept procedure, drawing ire from ACR and SIR.

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