Sterling kicks off DirectRay sales following FDA 510(k) clearance

Announcement caps $60 million, eight-year R&D effort

The final piece in the puzzle fell into place on July 1 for Sterling Diagnostic Imaging. The Greenville, SC-based digital radiography developer received Food and Drug Administration 510(k) clearance for its iiRad operator console, removing the final barrier for the firm to begin marketing complete systems utilizing its DirectRay technique in the U.S. Sterling also expects to receive its European CE Mark this month.

The iiRad operator console is the primary control device for capturing and configuring images from the DirectRay detector array and array controller, according to Sterling. In addition to serving as the user interface to x-ray generation equipment, the console acquires patient and exam data and routes images and information to printers, storage, and display devices.

The first complete iiRad systems to hit the market will be the DR1000 general-purpose radiographic and DR1000C dedicated chest radiographic systems. DR1000 features a ceiling-mounted U-arm with variable source-to-image distances to allow for a full range of radiographic studies, while DR1000C employs a servo-linked bucky to permit the operator to automatically center the x-ray tube by physically moving the bucky, according to Sterling.

Both DR1000 and DR1000C systems include a DirectRay detector array and array controller, iiRad operator console, automatic exposure control, automatic array positioning, and an 80-kW generator and associated electronics, according to the company. Worldwide shipments for both units are expected to commence in October, and the company has already begun taking orders for the systems.

Sterling has placed its first DR1000C into beta testing at the Christiana Care Health System in Wilmington, DE. First patient exposures with the unit began in late June.

Although it prefers to keep pricing information private, the company did say that prices of complete iiRad systems would range as high as $400,000. Other additions to the iiRad digital radiography line are planned, according to the firm.

In preparation for the October shipments, Sterling has ramped up its detector manufacturing efforts. Fischer Imaging of Denver will be manufacturing complete iiRad systems, and it holds rights to sell its own x-ray systems with Sterling’s detectors under the iiRad label. Service and installation of the exposure subcomponents of the iiRad integrated systems will also be handled by Fischer. In other product distribution agreements, Acoma Medical Imaging has an OEM deal with Sterling.

In addition to sales of complete systems, Sterling hopes to equip legacy radiography systems in the field with DirectRay technology, which will allow hospitals to convert to a digital environment without completely replacing their existing x-ray equipment. The first digital retrofit upgrades in the U.S. will be installed in the fourth quarter of this year, according to the company.

Sterling also would like to provide its detectors to conventional x-ray companies that are seeking ways to offer digital versions of existing analog-based products. The company is in discussions with several conventional x-ray vendors regarding possible OEM relationships, said Ernest Waaser, executive vice president and COO.

A Major Step. The FDA clearance of DirectRay is a milestone in the development of digital radiography systems. While companies such as Swissray, AID, and Oldelft are already offering digital radiography systems, Sterling is widely regarded as having greater resources and a better market position to leverage for digital radiography sales.

Sterling is one of the top two suppliers of x-ray film in the U.S. and will be able to leverage this large installed base for sales of iiRad systems. In addition, Sterling has numerous customers with iiLinx printer network installations to call on. The company also has a jump on multimodality OEMs such as Philips, GE, Siemens, and others who are developing flat-panel-based systems.

In contrast to the CCD-based digital x-ray systems that arrived on the market in 1998, Sterling’s DirectRay sensors are based on an amorphous selenium thin-film transistor panel that converts photons into analog voltage, which is then converted into digital signals by analog-to-digital converters. Since no light or scintillators are employed, DirectRay is a true direct digital device, according to the firm. The detectors generate images with resolution of 3.9 line pairs/mm and a 139-micron pixel size.

The FDA’s action sets the stage for a confrontation between Sterling’s version of direct radiography and the computed radiography approach espoused by Fuji Medical Systems U.S.A. of Stamford, CT. Sterling will most likely emphasize the elegance of DirectRay in moving x-ray data into digital networks, while Fuji will probably focus on the cost benefits its technology enjoys in comparison with DirectRay.

Although Sterling believes strongly in the image quality and benefits of DirectRay, the company also sees the benefits of an integrated solution. As such, Sterling views PACS as a key component in its product line, and has rounded out its iiSys PACS offerings with the commercial release of its display and review stations and teleradiology capabilities.

“Much of the development path of this company has been set toward creating the digital radiology department that has digital capture for conventional x-ray and the ability to move that image around, communicate it, display it, archive it electronically, and output it onto new generations of dry printing systems,” Waaser said.

Sterling has incorporated display software from partner ISG Technologies of Mississauga, Ontario, and now has available four different workstations, three of which are based on the Windows NT operating system.

Sterling has also introduced its iiSys image transmission line, a teleradiology package that includes software provided by Access Radiology of Waltham, MA. The offerings include the iiSys compression server, which features Framewave wavelet compression from Access. The iiSys DICOM bridge connects DICOM modalities, while the iiSys framegrabber provides connectivity and image capture for non-DICOM modalities.