FDA approves GE Healthcare’s Q.Clear technology

8 April 2014 (Last Updated April 8th, 2014 18:30)

GE Healthcare has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Q.Clear technology that can provide up to two times improvement in both quantitative accuracy and image quality in positron emission tomography (PET)/computed tomography (CT) imaging.

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GE Healthcare has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Q.Clear technology that can provide up to two times improvement in both quantitative accuracy and image quality in positron emission tomography (PET)/computed tomography (CT) imaging.

Q.Clear provides a fully convergent PET image reconstruction technique, enabled by controlling image noise through regularised reconstruction.

According to the company, Q.Clear has been designed to provide high quality images and consistent and accurate quantitation.

This new technology enables clinicians to assess patient's response to treatment accurately across the entire care continuum, including diagnosis, staging, treatment planning, and treatment assessment.

GE Healthcare's Q.Clear technology helps clinicians detect smaller lesions and to determine early whether the patient is responding to current treatment by providing better quantitation accuracy for truly personalised medicine.

"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."

When coupled with GE Healthcare's Q.Suite, which introduced the importance of eliminating variability such as respiratory motion, Q.Clear can enable clinicians to assess treatment response accurately so they can provide the best patient care.

GE Healthcare MICT president and CEO Steve Gray noted that approximately 70% of cancer patients do not 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," Gray said.

"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. The technology is yet to receive CE Mark approval.


Image: GE Healthcare's Q.Clear technology - SUVmax 10.1. Photo: courtesy of GE Healthcare.