FDA Grants 510(k) Clearance To GE Healthcare's Q.Clear Tech
GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of its Q.Clear technology in PET/CT imaging. Q.Clear allows clinicians to evaluate patient’s response to treatments more accurately than standard PET image reconstruction technologies.
Q.Clear technology provides up to two times the improvement in image quality as well as quantitative accuracy compared to other imaging technologies. GE said the tool can be used across the entire care continuum including diagnosis, staging, and treatment planning and assessment.
Steve Gray, president and CEO of GE Healthcare MICT, said, “We know that approximately 70 percent of cancer patients don't always respond to their initial course of treatment. 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 will be offered together with Q.Suite, a complementary tool that introduced the importance of ruling out variability such as respiratory motion in PET/CT imaging. Clinicians need high image quality and quantitation to detect smaller lesions and determine patients’ response to current treatments as early as possible.
Dr. Gustav von Schulthess, Nuclear Medicine Chair at University Hospital Zurich, said, “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. 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.”
The technology is not available for sale in all regions. Q.Clear is not yet CE marked and cannot be marketed or used in countries that require CE marking.