The FDA-approved technology developed by HeartFlow can predict a patient's long-term risk of target vessel failure as well as more invasive treatments performed inside a cath lab.
This is a Class I recall, which means using the device “may cause serious injuries or death.” However, the FDA emphasized that this is a correction and not a product removal.
President Joe Biden signed a funding bill worth $460 billion on March 9, but it only included partial relief for cardiologists, cardiac surgeons and other cardiology professionals.
“Our approach is like deploying tiny guards to protect blood vessels from going bad, so that there is no need to open the body over and over again to repair them,” one specialist explained.