FDA Grants E-QURE Approval to Initiate Clinical Trial
Delaware-based E-QURE was granted conditional approval by the FDA of its investigational device exemption for a U.S. clinical trial.
The company was approved based as a precondition to initiating the clinical trial on the first 10 patients, out of 90 planned patients, to ensure that no severe safety issues were found. The company will then continue the trial for all 90 patients.
The device is designed for the treatment and cure of chronic wounds such as: pressure ulcers; diabetics foot ulcers; venous stasis ulcers; and hard-to-heal ulcers. — Cynthia Jessup