Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs. 

These safety issues have been linked to more than 800 injuries and two deaths. It is possible, the FDA warned, that some patients may require a device to be removed and replaced. 

Generative AI is altering the way healthcare consumers size up hospitals, group practices and individual providers. But the comparison shopping would pose a challenge to healthcare organizations even if AI hadn’t entered the picture. 

Sonny Saggar, MD, a physician working for St. Louis General Hospital, billed Medicare and Medicaid for patient visits his unqualified assistants conducted. He pleaded guilty to conspiracy. 

The global medtech company is also looking to expand its organ transplant and ECMO portfolios.

In an SEC filing, the insurer argues that requests by investors for more reporting on claims denials may already be satisfied through its regulatory compliance processes. 

Add this to the list of high-risk healthcare activities to which generative AI can contribute: prescribing antibiotics. 

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”