Liver Disease Early Diagnosis Device Developed at Hadassah Medical Center Receives Exemption from FDA, Providing Fast Track for Approval
BreathID, a noninvasive early diagnosis device for acute liver failure developed at the Hadassah University Medical Center, has obtained a United States Food and Drug Administration (FDA) Humanitarian Device Exemption, which provides a fast-track toward approval. Prof. Yaron Ilan, Director of Hadassah's Department of Internal Medicine A is Medical Director of BreathID's developer, Exalenz Bioscience Ltd., a startup company of Hadasit, Hadassah's technology transfer arm.
The device, as well as saving lives through early diagnosis, can lead to the elimination of unnecessary liver transplants. The humanitarian use device (HUD) designation which BreathID received means that the device does not have to undergo an efficacy trial, thereby greatly shortening the approval process if it meets FDA requirements. BreathID's effectiveness in diagnosing acute liver failure was demonstrated in a trial of several dozen patients at Hadassah and London's Kings College.
The FDA has already approved a clinical trial of the BreathID device for the early diagnosis of Hepatocellular Carcinoma, a liver cancer.