Device label expansion using real-world data

Device label expansion using real-world data

US spending on medical devices and in-vitro diagnostics totals more than $199 billion a year, with most of the costs associated with clinical development. Label expansion provides a pathway for recouping costs associated with the device development process by...
Off-label use of drugs and devices in medical practice

Off-label use of drugs and devices in medical practice

A common misconception is that drugs and devices must gain explicit approval from the FDA for each specific use before healthcare providers can employ them. However, a practice known as off-label use challenges this notion, revealing a broader landscape of treatment...
Transforming heart health research with EHR data

Transforming heart health research with EHR data

Heart disease is a massive crisis in this country. Ranking as the leading cause of death in the US for more than a century, heart disease takes a life approximately every 33 seconds. That’s about the same time it takes an average person to blink eight times. Although...