FDA sees through GE Q.Clear PET/CT image reconstruction

GE Healthcare announced yesterday that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for the company’s PET/CT iterative image reconstruction technology that works to improve image quality and quantitative data.

The software is an add-on to GE’s existing PET/CT systems for diagnostic imaging, as well as disease staging and treatment planning, and therapy monitoring.

"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," Gustav von Schulthess, MD, PhD, professor and chair of nuclear medicine at University Hospital Zurich, in Zurich, Switzerland, said in a press release. "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 objective of iterative image reconstruction is to make PET/CT images clearer while lowering injected dose and the time it takes to acquire images. The industry has been at this for more than 10 years. GE released a statement saying that Q,Clear surpasses previous limitations in time-of-flight technologies and ordered subset expectation maximization in order to find more and small lesions when it comes to oncologic imaging.

"We know that approximately 70 percent of cancer patients don't always respond to their initial course of treatment," Steve Gray, president and CEO of GE Healthcare’s molecular imaging business, said in the 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." 

This technology is not available everywhere and has not yet received a CE mark from the European Commission for European sale of Q.Clear.