GE builds multislice SPECT/CT but limits sales to luminary R&D sites

January 24, 2005

GE Healthcare has no immediate plans to release a commercial multislice SPECT/CT, despite obtaining an FDA 510(k) on such a device last month, according to company executives.

GE Healthcare has no immediate plans to release a commercial multislice SPECT/CT, despite obtaining an FDA 510(k) on such a device last month, according to company executives.

GE sought FDA clearance so it could install prototypes of a multislice CT in at least three luminary sites around the world. The goal is to explore possible clinical uses for this hybrid technology.

"It is a research project," said Dave Burleton, global product manager for Infinia and Infinia Hawkeye, GE's hybrid gamma camera and nondiagnostic CT. "It is not intended to go commercial."

Only one site is currently operating a multislice SPECT/CT from GE. Company executives refused to elaborate on system specifications, particularly the number of slices per rotation, stating only that each luminary site has or will be equipped with whatever hardware configuration is necessary to satisfy its clinical needs.

GE is focusing on developing clinical applications, primarily in oncology and cardiology. Sixteen-slice CTs are better suited than quadslice systems to cardiologic applications. Those with 64 are even better, Burleton said.

At the RSNA meeting GE showed a work-in-progress PET/CT featuring a 64-slice LightSpeed VCT that will not be available for more than a year. The company did not, however, show a work-in-progress multislice SPECT/CT, even though such a device is in development. The reason, according to Michelle Heying, general manager of GE's global nuclear medicine, has partly to do with the market for these products.

"We are 100% committed to Infinia Hawkeye," she said. "We don't want to disrupt the market and confuse customers to think that the only way to go (with SPECT/CT) is with a diagnostic CT. That is absolutely false."

Showing a 64-slice PET/CT, on the other hand, will have virtually no effect on the marketplace. The current generation of PET/CTs is used almost exclusively in oncology, whereas 64-slice PET/CTs would be applied in cardiology.

The company might, at some future time, develop a commercial version of multislice SPECT/CT, Heying said. The configuration of such a product and when it might be released will depend heavily on clinical results obtained at GE luminary sites. The company will also factor in customer demand for multislice SPECT/CTs.

Siemens Medical Solutions and Philips Medical Systems plan to launch commercial versions of multislice SPECT/CTs later this year. The companies unveiled their products at the Society of Nuclear Medicine meeting last June (SCAN).

So far, the added talk about SPECT/CT seems be helping sales of the Infinia Hawkeye. Ian Brown, GE's Americas sales and marketing manager for nuclear medicine, said the company shipped the most SPECT/CT systems ever in the quarter immediately following the SNM meeting.

"In Q4, we broke that record all over again," he said.

Last year, the company shipped well over 100 Infinia Hawkeyes, according to Brown. Since it began delivering SPECT/CT some five years, GE has shipped more than 500 such systems.