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 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.

Cardiology is No. 2 behind radiology when it comes to FDA-cleared AI algorithms. Neurology, meanwhile, is a distant No. 3. 

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.

Freestanding EDs demonstrated meaningful operational advantages over hospitals when using an accelerated troponin pathway. This included earlier discharges for low-risk chest pain patients.

Researchers have developed an advanced AI model capable of detecting signs of severe AS, mitral regurgitation and other complications in ECG results. For example, one 84-year-old patient who was hospitalized for a fractured femur ended up being scanned and treated with TAVR just days later.

The AI model showcased an ability to accurately identify signs of pulmonary hypertension in retinal images. "This opens the possibility of using a simple photograph to gain insights into a premature infant's overall health," one researcher explained.

The new-look TAVR system was linked to multiple benefits after one year. The cardiologists evaluating this device belief it could significantly reduce the risk of long-term valve degeneration.