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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.

Over a dozen lawsuits claim Ozempic and Wegovy caused patients to go blind

The lawsuits, filed in multiple states, contend there's a causal link between semaglutide and a rare condition called NAION that leads to diminished eyesight. Plaintiffs want the popular weight-loss drugs to add a warning label.

CMS outlines policy shifts for ACO REACH model to align with MAHA

The Centers for Medicare & Medicaid Services is updating the ACO REACH program—which supports providers caring for rural and low-income populations—to promote patient health as a strategy to reduce costs.

Predictive model helps identify malignancy in thyroid nodules.

Predictive model uses 6 ultrasound features to differentiate between benign and malignant thyroid nodules

Once the model is further validated, it could help guide providers in determining how to manage thyroid nodules.

Meril TAVR valves linked to 1-year outcomes similar to industry-leading devices from Medtronic, Edwards

Indian medtech company Meril Life Sciences has been manufacturing its Myval TAVR valves for years, but FDA approval has remained out of reach. These latest data represent a one-year update of the multicenter LANDMARK clinical trial.

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