GE Healthcare announces FDA clearance for image technology

Special to The Freeman

April 8, 2014

WAUKESHA – GE Healthcare announced Tuesday it has received U.S. FDA clearance for its Q.Clear technology that can provide up to two times improvement in both quantitative accuracy and image quality in PET/CT imaging.

“Q.Clear is a major step forward because it can give us a consistent and reliable measurement when determining whether the current course of a patient's cancer treatment is effective,” said Dr. Gustav von Schulthess, nuclear medicine chair at University Hospital Zurich, in a statement. “It will give the oncologist more confidence because if a change of therapy is needed, you want accurate information early on to best adjust treatment for the patient.”

GE Healthcare’s new Q.Clear technology shows the advantage of full convergence PET imaging with no more compromise between quantitation and image quality, according to the announcement.

“We know that approximately 70 percent of cancer patients don’t always respond to their initial course of treatment,” said Steve Gray, president and CEO of GE Healthcare MICT, in a statement. “If we can give clinicians an accurate, reliable, and faster tool to confirm that a change in treatment is needed, the patient will benefit greatly. For example, PET/CT can help clinicians determine whether chemotherapy is working in fewer cycles, saving patients unnecessary procedures. Q.Clear gives clinicians the ability to help make that determination.”

Q.Clear technology is not available for sale in all regions. For countries that require CE marking, Q.Clear is not yet CE marked and cannot be placed on the market or put into service in such countries until it is made to comply with CE marking.

Waukesha-based GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable health care around the world.