Medical device company InfraScan has received a green light from the U.S. Food and Drug Administration to market its handheld device to detect bleeding in the brain. The FDA granted approval for the infrascanner to be marketed through a de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are […]
When it comes to brain trauma, time is of the essence, or as Infrascan CEO Baruch Ben Dor puts it: time lost is brain lost. A handheld medical device designed to detect bleeding in the brain, the Infrascanner, is designed to be used as a sort of triage device by first responders and physicians to […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.