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GE Healthcare’s Discovery IQ receives FDA 510(k) approval

GE Healthcare has received 510(k) approval from the US Food and Drug administration (FDA) for its Discovery IQ PET/CT system.

CT system

The new system with Q.Clear technology has been developed to offer accurate quantitation (SUVmean) with better image quality (SNR) for small lesion detection, fast and efficient reading, and a confident diagnosis, noted GE.

Discovery IQ is said to provide National Electrical Manufacturers Association (NEMA) sensitivity up to 22cps/kBq, and axial field-of-view up to 26cm.

GE Healthcare PET/CT general manager Wei Shen said that around 50% of people will develop cancer at some point in their lives by 2020, while currently about 70% of cancer patients do not respond to their initial chemotherapy treatment.

"I’m excited about the recent FDA clearance of Discovery IQ, which will help physicians achieve their primary mission of delivering the best possible patient outcomes. And, by making Discovery IQ mobile-ready, we engineered it to be accessible to more patients in more places, allowing for high-performance PET/CT clinical care to whoever needs it," Shen added.

GE said that Q.Clear technology delivers no trade-off between image quality and quantitative SUV measurements.

Image: GE Healthcare’s Discovery IQ PET/CT system. Photo: courtesy of General Electric.