GE Healthcare announces FDA clearance of lesion-detecting device

GE Healthcare has announced U.S. Food and Drug Administration 510(k) clearance of its Discovery IQ PET/CT system, a device that will help physicians detect smaller lesions and determine whether the patient is responding to current treatment. PET/CT is a new imaging tool that combines two scan techniques – a PET scan and a CT scan – in one exam.

Discovery IQ delivers the highest NEMA (National Electrical Manufacturers Association) sensitivity and the largest axial field-of-view compared to other market-leading PET/CT equipment. This system can image with both half the PET dose and half the scan time. Discovery IQ, with GE’s new Q.Clear technology, is designed to provide more accurate quantitation with excellent image quality for small lesion detection, fast and efficient reading, and a confident diagnosis.

“By 2020, it’s estimated that 50 percent of people will develop cancer at some point in their lives, and we also know that currently approximately 70 percent of cancer patients do not respond to their initial chemotherapy treatment,” said Wei Shen, general manager of GE Healthcare PET/CT. “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.”

GE Healthcare’s U.S. headquarters is located in Wauwatosa.

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