GE Healthcare’s Discovery IQ system receives 510(k) clearance from FDA

23 September 2014 (Last Updated September 23rd, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for GE Healthcare's Discovery IQ PET/CT system.

CT system

The US Food and Drug Administration (FDA) has granted 510(k) clearance for GE Healthcare's Discovery IQ PET/CT system.

GE Healthcare said that the new system can image with both half the Positron emission tomography (PET) dose and half the scan time.

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

Compared with other PET/CT equipment, the new system is designed to offer National Electrical Manufacturers Association (NEMA) sensitivity up to 22cps/kBq, and axial field-of-view up to 26cm.

"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."

GE Healthcare PET/CT general manager Wei Shen said: "By 2020, it's estimated that 50% of people will develop cancer at some point in their lives and we also know that currently, approximately 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."

The new Q.Clear technology delivers no trade-off between image quality and quantitative SUV measurements.

The company said that the new system provides benefits to physicians across the cancer care continuum from diagnosis and staging to treatment planning and assessment.


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