Signaling a new phase in the race to computerize hospital radiology departments, Sterling Diagnostic Imaging has become the first manufacturer to win approval from the Food and Drug Administration for a full-size direct digital X-ray system.
The Greenville, S.C.-based company announced the filmless X-ray milestone at the Radiological Society of North America meeting last week in Chicago.
"We are delighted," said G. Rodney Wolford, chief executive officer of Sterling and former CEO of Alliant Health Systems, Louisville, Ky.
Although 70% of radiology exams are X-ray studies, the equipment is the last in radiology departments to go digital. Digital X-ray systems promise the direct capture of imaging information for speedier diagnosis, easier archiving and electronic transfer of images between distant locations.
But the real selling point for the high-priced digital X-ray machines is the elimination of film expenses.
"For a big, high-volume radiology department, you can save 70% of your film budget in perpetuity," said William Davros, chief of diagnostic medical physics at the Cleveland Clinic Foundation, a test site for the Sterling technology.
In tandem with the announcement of FDA approval, however, Sterling detailed an about-face in marketing strategy -- electing first to sell the digital capture technology as part of integrated X-ray systems manufactured by Fischer Imaging Corp., Denver, rather than as upgrades to installed equipment.
The company expects the new systems to cost between $300,000 and $350,000 and to be commercially available by mid-1998. Sterling later will offer upgrades to installed X-ray equipment.
Selling integrated systems first is calculated to show the technology off to full advantage, the company said. That's necessary to pave the way for its broader acceptance. Though upgrades are likely the larger market, they must be customized by equipment type, which complicates quick adoption.
Chemical giant E.I. Du Pont de Nemours & Co., Wilmington, Del., spun off its medical imaging business, primarily a maker of X-ray film, as Sterling in 1996.
Notwithstanding the luster of its digital technology, Sterling has no plans to abandon its X-ray film lines.
"We have not forgotten our roots in film," Wolford said at an RSNA news conference. "With as much revenue as we get from film, it's hard to forget."