FDA Commissioner Robert Califf, MD, explains the need for hospitals to perform quality assurance checks on clinical artificial intelligence to ensure these technologies don't "drift" from what was originally cleared by the FDA.
 

This update helps ensure Artivion's AMDS Hybrid Prosthesis can be used to treat high-risk patients as the FDA makes its final approval decision. The news came as Artivion works to bounce back from a cybersecurity attack that occurred in November.

Many of these exams are ultimately deemed normal, and their results often do not affect how patients’ headaches are managed. 

The Florida-based healthcare company, already a leading name in cardiac data management, said the acquisition will help its technology reach more heart teams than ever before.

Both patients and physicians were impacted by the incident, with outside forces gaining access to everything from names and social security numbers to banking information. 

At its current rate, the number of clinical AI models cleared by the FDA will break 1,000 before the end of 2024. Cardiology continues to play a significant role in this ongoing trend. 

This partnership reflects NextGen Healthcare’s deepening commitment to supporting cardiology practices nationwide. Research shows that nearly 50 percent of adults in the United States have some form of cardiovascular disease today—a rate expected to grow to 61 percent by 2050.

Medicare rescinded the provision in the 2024 Medicare Physician Fee Schedule, but the law remains on the books.