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

Wednesday, Nov 30 2016

Hadassah Teams Up with Spinal Cord Institute to Study Outcomes of Traumatic Injuries

The medical interventions and outcomes for Israelis with a spinal cord injury (SCI) will now be captured in the Rick Hansen SCI Registry (RHSCIR), thanks to the November 16th launch of a partnership between the Hadassah Medical Organization and the Rick Hansen Institute (RHI), a Canadian-based not-for-profit organization named after the paralympic athlete who suffered a severe spinal cord injury following a car accident.

READ MORE ›
alt_text

Thursday, Nov 17 2016

A Birthday Party in Hadassah’s PICU: Helping a Four-Year-Old Recover

Yehoshua "Shuki" Pepper was crossing a Jerusalem street with an older sibling when a car ran him over. He was rushed to Hadassah Hospital Ein Kerem's Pediatric Intensive Care Unit in fair condition, but he wasn't speaking and subsequent MRIs of his head injury were worrisome.

READ MORE ›
alt_text

Thursday, Nov 17 2016

Ethiopian Pre-Nursing Students: On the Way to Fulfilling a Dream

“I know that some people are fine with looking at a screen all day, but I know I need the human touch--to work with people. I want to be a nurse, " relates Sarah Talala, one of the 18 students of Ethiopian background who were given the opportunity to take a course which enabled them to advance to pre-academic studies at the Hebrew University and then on to nursing school at the Hadassah-Hebrew University Henrietta Szold School of Nursing.

READ MORE ›
alt_text

Monday, Nov 14 2016

Granalix BioTechnologies Introduces Food Additive to Protect Against Neurodegenerative Disease

Granalix BioTechnologies, whose founder and Chief Executive Officer is Hadassah Medical Organization Experimental Neurologist Prof. Ruth Gabizon, has launched a food supplement containing pomegranate oil that has proven to protect against neurodegenerative diseases in pre-clinical models.

READ MORE ›

Contact Us

40 Wall Street

New York, NY 10005

support@hadassah.org

More ›

Membership Questions

membership@hadassah.org

(800) 664-5646

Donation Questions

donorservices@hadassah.org

(800) 928-0685

Missions Department

missions@hadassah.org

(800) 237-1517

Show More