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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 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. 

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." 

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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.

Lantheus receives tentative FDA approval for its radio-equivalent to Lutathera

Lantheus’ version of a radiopharmaceutical capable of targeting somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) has been tentatively approved by the FDA.

After traversing the aortic cusp with an electrified wire and balloon inflation, a stent is positioned inside the noncoronary cusp and deployed. Immediately after, a transcatheter aortic valve is expanded, and the stent is crushed on the left ventricular outflow tract wall and annulus, while anchored to the aortic valve leaflet.
Cardiologists perform first TAVR of its kind by anchoring valve to crushed stent

The patient, 78, presented with severe AR and no signs of calcification. She was considered a poor choice for surgery or traditional TAVR due to multiple risks. That is where the new-look ATLAS technique came in.

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Ablation as effective as surgery for certain kidney cancers

Typically, these cancers are treated via surgical resection, but ablative techniques have gained recognition in recent years due to their less invasive nature. 

cardiologist salary and compensation data
Did you make the list? CMS targets cardiologists for new heart failure payment model

More than 2,000 cardiologists are required to participate in the new payment model. According to CMS, the long-term goal is to track and reduce the high healthcare costs associated with treating heart failure.

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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