News

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.

court judge gavel business man bankruptcy lawsuit

Radiology practice’s severance agreement is unlawful, National Labor Relations Board rules

Leena Mammen, MD, first brought the complaint against Fayetteville-based Valley Radiology in 2023.

FDA approves 1st AI-enabled imaging device for breast cancer surgery

Manufacturer Perimeter Medical Imaging announced the news on March 3 after earning premarket approval for “Claire” (formerly the Perimeter OCT B-Series).

Bayer's MR contrast injection system cleared by FDA for expanded use

The updated clearance expands the system's labeled field strength compatibility; the change will allow MRI suites with scanners up to the 7T range to utilize the system.

Financial aid nonprofits merge to do more for patients feeling pinched by medical bills on top of overall inflation

Two medical charities that last year gave $640 million to 200,000 struggling Americans are combining forces so they can expand their collective wherewithal.

Around the web

Health Exec

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