FDA Clears GE Healthcare’s Q.Clear Technology

GE Healthcare plans to roll out its Q.Clear imaging technology in the U.S. over the next several months, following 510(k) clearance by the FDA. The device provides up to twice the improvement in accuracy and image quality in PET and CT imaging, the company says.

Q.Clear combines hardware and software to create a “fused image using PET info and the CT imaging as an anatomical map,” GE spokeswoman Wei Shen told Device Daily Bulletin. That map helps clinicians determine how many tumors a patient has, whether they have metastasized, and what stage they happen to be.

Having a more accurate indication of a tumor’s stage and metabolic activity aids oncologists in determining disease stage and the efficacy of chemotherapy, which could lead to fewer unnecessary treatments for patients, the devicemaker says.

According to Shen, conventional methods provide a trade-off between image quality from a scan and the ability to calculate an accurate measure of a lesion’s metabolic activity. Since cancer cells consume more glucose than healthy cells, the most common tracer used in PET imaging is glucose-based, causing the lesion to present brighter in a PET image.

The problem with calculating an accurate number, Shen said, is that a lot of variables, such as body weight, fasting, exercise and time between tracer injection and image reading, can impact the calculation.

Q.Clear’s breakthrough, she said, “is presenting both a better image and a better number.”

The technology is already cleared for marketing in Japan. GE Healthcare expects CE marking and commercial launch in Europe to begin with the next few months. — Lena Freund

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