Sterling gets FDA go-ahead to market full iiRAD systems

Sterling gets FDA go-ahead to market full iiRAD systems

Vendor also completes rollout of PACS offering

The wait is over. Sterling Diagnostic Imaging has received Food and Drug Administration 510(k) clearance for its iiRAD operator's console, removing the last barrier for the company to begin marketing complete systems based on its DirectRay digital radiography concept.

Sterling will immediately begin sales of its DR1000 general-purpose radiographic and DR1000C dedicated chest radiographic systems. Worldwide shipments are expected to commence in October for both systems, said Ernest Waaser, executive vice president and COO for the Greenville, SC-based company.

Although Sterling prefers to keep list prices private, the company did say that systems would range as high as $400,000. Sterling has submitted its application for the European CE Mark and expects to receive European clearance in July.

The FDA clearance was much anticipated in the medical imaging market, and the company's success will be closely monitored. While Swissray, AID, and Oldelft (see story, page 3) beat Sterling to the U.S. market with their digital radiographic systems, Sterling is better known in the U.S. and has the luxury of being to able to leverage its large installed base of film users for sales of DR-based systems.

Sterling also has the benefit of additional OEM distribution channels for its technology. Fischer Imaging will be manufacturing the complete iiRAD systems and, in addition to its manufacturing contributions, will hold rights to sell its own x-ray systems with Sterling's detectors under the iiRAD label. Acoma Medical Imaging also holds an OEM deal with Sterling. Furthermore, Sterling hopes to sell its detectors to other x-ray vendors for incorporation into their x-ray systems.

On the technology side, Sterling is the first company to receive clearance for a non-CCD-based digital radiography system. Sterling's DirectRay detectors are based on an amorphous selenium thin-film transistor panel that converts x-ray photons into analog voltage, which is then converted into digital signals by analog-to-digital converters. No dedicated reader is needed for the detectors, which yield images with resolution of 3.9 line pairs/mm and a 139-micron pixel size.

Sterling's technology, initially called Direct Radiography, was first introduced to the radiology community at the 1995 Radiological Society of North America meeting by Du Pont's Medical Products Group, before that unit became Sterling Diagnostic Imaging in a divestiture by the chemical giant. Although commercialization was not scheduled until 1998, the detectors captivated RSNA attendees who jammed Du Pont's booth at the show.

At the 1996 RSNA meeting, Sterling showcased 14 x 17-inch versions of its detectors and followed that up at the 1997 RSNA show by displaying complete DR1000 and DR 1000C systems. The company renamed the technology DirectRay prior to the meeting. Sterling believes its detectors offer the only true direct-to-digital technology.

The onset of digital radiography systems obviously holds much potential in PACS. In fact, Sterling executives view PACS as a key component of its overall offerings.

"Much of the development path of this company has been set towards 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.

As part of this vision, the company has rounded out its iiSYS PACS line with the commercial release of its display and review stations and teleradiology capabilities. Incorporating display software from partner ISG Technologies of Mississauga, Ontario, Sterling has made available four different workstations, three of which are based on the Windows NT operating system.

For clinician and referring physician access to images from home or office, Sterling offers iiSYS display 200. Another workstation, iiSYS display 400, is a single or dual portrait monitor system targeted for clinicians in environments such as critical care.

Radiologists and clinicians could utilize iiSYS display 600, a multipurpose display station designed for interpretation of digital general radiography and multimodality exams, according to Sterling. The company also offers a Unix-based version of iiSYS display 600, which provides more advanced viewing functionality such as cross-sectional referencing. Radiologists, oncologists, surgeons, and other physicians are expected to make use of the Unix version.

On the teleradiology side, Sterling has introduced its iiSYS image transmission line, which includes software provided by Access Radiology of Waltham, MA. The offerings include iiSYS compression server, which features Framewave wavelet compression from Access. The iiSYS DICOM bridge connects DICOM modalities, while iiSYS frame grab provides connectivity and image capture for non-DICOM modalities.

An iiSYS film digitizer product processes and digitizes conventional film, and the iiSYS at-home software provides image transmission and display for on-call radiologists or clinicians at their home or office.

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