Hadassah

Liver Disease Early Diagnosis Device Developed at Hadassah Medical Center Receives Exemption from FDA, Providing Fast Track for Approval

Monday, Oct 24 2011

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.

Comments

No comments yet.
First Name
Email
Comment
Enter this word:

Related Stories

alt_text

Monday, Oct 9 2017

Honoring a Hadassah Leader's Legacy with Increased Breast Cancer Programming

Jill Stenzler-Engelman devoted 15 years to Hadassah's Check It Out® breast cancer awareness program in St. Petersburg, Florida. She taught breast self-exam and early detection at high schools, jails, and more. Her husband, Dr. Greg Engelman, said, “Jill loved to teach and loved educating young adults and adults on being proactive about their health.” Sadly, after a courageous 10-year battle, Jill died of ovarian cancer at age 53.

READ MORE ›
alt_text

Monday, Oct 9 2017

Dr. Tamar Elram Announcement

The administration of Hadassah Medical Organization is pleased to announce the selection of Dr. Tamar Elram as the new Director of the Hadassah Mount Scopus Hospital.

READ MORE ›
alt_text

Wednesday, Oct 4 2017

Hadassah Medical Organization Sends Top Adolescent Trauma Expert to Mexico to Aid Earthquake-Ravaged Victims

Hadassah has sent one of the world’s top experts on adolescent Post Traumatic Stress Disorder Syndrome (PTSD) to Mexico City.

READ MORE ›
alt_text

Wednesday, Oct 4 2017

National Board Member’s Grandbaby Saved by Hadassah Heart Specialists

Long-time National Board Member Helaine Ohayon has been a devoted supporter of the Hadassah Medical Organization for many a year.

READ MORE ›

Donation Questions

donorservices@hadassah.org

(800) 928-0685

Membership Questions

membership@hadassah.org

(800) 664-5646

Missions Department

missions@hadassah.org

(800) 237-1517

Contact Us

40 Wall Street

New York, NY 10005

support@hadassah.org

More ›

Show More