FDA okays rotating chair for SPECT

September 8, 1993

A chair that promises to transform old planar systems into cardiacSPECT systems was cleared last month by the Food and Drug Administrationfor commercial sale in the U.S. The device, which is being soldin the U.S. by MEDX, Inc. of Wood Dale, IL, is

A chair that promises to transform old planar systems into cardiacSPECT systems was cleared last month by the Food and Drug Administrationfor commercial sale in the U.S. The device, which is being soldin the U.S. by MEDX, Inc. of Wood Dale, IL, is designed specificallyfor the retrofit market.

"It's a very cost-effective way of getting into cardiacSPECT--as long as the planar camera has good resolution, goodlinearity and good uniformity," says Brian Sinder, MEDX vicepresident of international sales.

The device, called the Specturn Tomo Chair, was developed byHarpell Associates of Oakville, Ontario, and is being offeredat an initial price of $16,500.

For the past two years, Scinticor Inc. of Milwaukee, has offereda SPECT chair for integration into existing systems. The Scinticorchair, which is designed specifically for cardiac scans, sellsfor about $70,000.

Scinticor bought its first three chairs from ATF of East Islip,NY. A year ago, Scinticor arranged to license the chair patentfrom ATF. The licensing arrangement provides ATF with a royaltyon each chair sold. The smaller firm had previously exhibitedits product directly at medical conferences, including those ofthe Radiological Society of North America and the Society of NuclearMedicine.

Upright SPECT is ideal for cramped spaces, since the chairand old gamma camera can fit into a 10 x 10-foot room. Patientsusing the new Specturn device kneel on the Swedish-style chair,their arms suspended in slings and their weight resting primarilyon their knees. A planar detector is turned in an upright positionand the chair, which is interfaced to the acquisition computer,turns until a complete cardiac scan is obtained, usually in 20to 30 minutes.

The Specturn Tomo Chair can be configured for brain tomographyand pelvic scans, as well as heart studies. But the FDA has clearedits sale only for commercial cardiac applications.

"As soon as we build up our clinicals, we will be reapplyingto the FDA to expand our description in the U.S. to cover brain,liver and so on," says Tim Harpell, president of HarpellAssociates Inc. "But until then, we're a cardiac chair forthe U.S. market."

The chair had been in review at the FDA for about a year.During that time, it was commercially available in Canada.

BRIEFLY NOTED:

  • Fresh from a successful settlement of a nuclear medicinepatent dispute with Sopha (SCAN 7/28/93), Elscint launched a newpatent infringement case against competitor ADAC Laboratorieslast month. The suit, filed in the U.S. District Court of Maryland,apparently involves both nuclear medicine and fluoroscopy technology.

ADAC's major business is nuclear medicine. The Milpitas, CA,vendor does not produce fluoroscopy systems, although it doesmanufacture digital angiography products. The suit came as a surpriseto ADAC. Elscint had raised patent issues over a year ago, andboth companies had been corresponding on the matter.

Although still reviewing the charges, ADAC feels it has a soundcase to defend and may seek relief from Elscint with a countercharge, the company said.

  • Varian Associates took steps as planned last week to buildthe organizational bulk and product line of its profitable HealthCare Systems Group (SCAN 11/4/92 and 3/24/93). The leading independentsupplier of medical imaging tubes and linear accelerators forcancer therapy purchased one of its most successful tube reloadersand launched a cooperative marketing and development effort ina new area of cancer treatment.

International X-ray Tube (Interay) of North Charleston, SC,is not merely a tube loader and service company. The firm distributesVarian (formerly Eimac) tubes. But it also runs its own R&Doperations, developing specialized tubes for manufacture to specificationsby Varian (SCAN 9/27/89).

One Interay forte was its design of replacement products forPhilips' entire line of cath lab tubes. Varian x-ray replacementtubes were sold to independent service organization and OEMS,such as Toshiba and GE. Four years ago, the company had $7 millionin sales. Owner and president Robert D. Hibdon will continue onas head of the new Varian business unit, which will likely retainthe Interay name in some form and remain located in South Carolina.

  • Expanding its cancer therapy line, Varian licensed therights last week to manufacture, sell and service high-dose brachytherapysystems outside the U.S. The technology, developed by OmnitronInternational of Houston, places a radiation source directly inor next to a tumor, using a catheter.

The high-dose technique allows treatment on an outpatient basis,in contrast to conventional brachytherapy. Such a therapy producteffort would be complementary to Varian's main, noninvasive acceleratorbusiness. Brachytherapy systems will be built at Varian's Britishfactory. The two firms will jointly develop new systems and upgrades.

  • Fast CT firm Imatron of South San Francisco reported lastmonth it has developed a reconstruction algorithm that shouldfurther speed CT processing capabilities. The Transform Back Projectionalgorithm was developed in a $500,000 program funded by partnerSiemens. Siemens will license the algorithm from Imatron.

Imatron also entered into an agreement with Computing DevicesInternational and Grumman Aerospace to apply for $2 million ingovernment funding for further development of TBP and advancedarray-processor hardware.

TBP reduces the number of computations required in CT reconstructionprocessing, according to the inventor and senior Imatron scientistDr. Jon Harman.

The TBP algorithm can be adapted for use with the large arraysin state-of-the-art array-processor microchips. It also providesfor enhanced three-dimensional reconstruction of image data fromnewer CT systems that use advanced scanner geometries.

"TBP represents the first major advance in CT reconstructionmathematics since the introduction of the popular filtered-back-projectionmethod in the mid 1970s and will be an essential building blockfor future fully three-dimensional volume CT systems," Harmansaid.

  • GE Hangwei Medical Systems will invest 60 million yuan($10.5 million) in a new CT plant in Beijing, according to a reportlast month in the China Daily. GE Medical Systems initiated theGE Hangwei Chinese joint venture two and a half years ago forlocal assembly of CT and ultrasound systems (SCAN 5/22/91).

The Beijing plant, which should be operational next year, willboth design and manufacture CT systems for sale throughout Asia.GEMS views China as the center for its Asian production, accordingto a statement attributed to GEMS-Asia president and CEO GoranS. Malm.

GE Hangwei's new facility, to be located in the Beijing Economicand Technology Development Zone, will use more local-made partsbut will continue to import some components. GE Hangwei is plannedas a 30-year venture, the China Daily said.