Lodox Systems's digital X-ray system offers low-dose, whole-body, lower-cost imaging for trauma centers, ERs, military field hospitals, and high-traffic facilities.
South African firm plans global marketing push
South African start-up Lodox Systems is challenging conventional thinking on emergency imaging with a new digital x-ray system that promises low-dose, whole-body imaging in about the same time as a CT scan but at lower cost.
The Statscan Critical Imaging System, which evolved from technology designed to spot diamonds being smuggled out of mines, is being billed as an improved solution for assessing trauma patients. The FDA-cleared system generates high-resolution head-to-toe images and close-up shots of suspected fractures in less than six minutes, according to clinical tests of the device.
Statscan uses a tightly controlled x-ray source that travels along the length of immobile patients. Transmitted x-rays reach a proprietary solid-state linear slot scanning detector, which moves with the source. The negligible scatter from a tightly focused x-ray beam avoids the need for a large area scatter reduction grid, an integral part of film and digital systems.
Statscan systems are running at two hospitals and one research center in South Africa. Receipt of FDA clearance in October 2002, however, means that Lodox can forge ahead with plans to launch the system from its North American office in South Lyon, MI.
"Statscan was developed from day one with the export market in mind. However, ironically, we are finding more and more interest from secondary healthcare institutions in South Africa that are interested purely because it is so easy and quick to get high-quality x-rays," said Herman Potgieter, CEO of the company and a prime mover in the device's metamorphosis from diamond detector to trauma scanner.
Lodox is awaiting a CE Mark, expected in Q3 2003, before more systems can be installed in South Africa. The country's Department of Health originally stated that either FDA approval or a CE Mark would be acceptable for its operation. But they changed their tune after Lodox submitted an application to the U.S. regulatory body first, Potgieter said. Government officials have since awarded special dispensation for Statscan systems to be used in South Africa for another 12 months with only FDA approval.
Worldwide sales, distribution, and customer service support is being handled out of the U.S. by wholly owned subsidiary Lodox Systems North America. The operation is being run by CEO William Greenway and marketing vice president Kevin Oakley. Venture capital funding is being provided by major South African investors De Beers, who initially prompted development of the low-dose human scanning system; the Industrial Development Corporation of South Africa; and Netcare, a large private hospital and doctor network.
Lodox plans to emphasize the U.S. medical imaging market, according to Oakley. Direct sales and customer service staff will be hired to support its initial rollout. Service-oriented dealerships and OEMs will likely be considered for future promotions outside of North America. Some early adopters have already placed orders for the $400,000 system. The first installation at a U.S. hospital is scheduled for May.
Oakley notes the system may prove especially helpful in trauma centers, hospital emergency rooms, military field hospitals, and areas requiring high-throughput general radiography. Statscan's highly focused beam will also benefit morbidly obese (bariatric) patients, whose oversized body parts can be difficult to scan with conventional x-ray systems, and pediatric patients, owing to the lower dose.
"Since we don't have to work with the negative effects of scatter, we only have to give enough radiation to produce an excellent picture, and that quality of picture can be produced with 10 to 15 times less radiation than any other type of x-ray system," he said.
Oakley described the system as an adjunct to emergency CT rather than a replacement. High-quality first-line screening with the Statscan could reduce the number of unnecessary trips to CT and save valuable time, he said.
"With Statscan, the patient can be screened in a couple of minutes, right in the trauma resuscitation room," he said. "If you find something at that point that needs further investigation, you can scan that area with the Statscan system at a higher definition level."