Rivalry in digital chest x-ray quickens as FDA clears Konica's Regius system

Rivalry in digital chest x-ray quickens as FDA clears Konica's Regius system

Film vendor expects to market system in 1999

The market for digital x-ray systems is getting hot as vendors respond to hospitals' increasing interest in upgrading their existing x-ray systems to capitalize on PACS technology. The latest company to bring a digital x-ray system to market is Konica Medical of Wayne, NJ, which received 510(k) clearance for its Regius digital chest system in June.

Konica introduced Regius at last year's Radiological Society of North America (RSNA) meeting (PNN 1/98), and the unit has been sold in Japan since 1996. The system's storage phosphor plate technology reflects an approach similar to computed radiography. But Regius differs in that its phosphor plates do not need to be removed and read separately by another piece of equipment. Therefore, data from a Regius system can be put directly into a PACS network. Konica executives believe the unit fills a unique position in the CR market.

"Portable phosphor technology has made great contributions to medical imaging, but especially at a time when the radiology community is trying to reduce costs, it's great to have (Regius) technology," said a company spokesperson.

In a Regius x-ray exposure, light interacts with thallium and rubidium-bromide on the system's phosphor plates. A laser reads the captured image, and the data goes through analog-to-digital transfer through a photomultiplier tube. Seventeen seconds after the x-ray exposure is terminated, the data appears on the operator console. Technicians can then send acquired images directly to a laser printer, or to another workstation.

Konica plans to place Regius in at least two clinical sites by fall and estimates that the unit will be commercially available in 1999. Depending on its configuration, the unit will carry a list price in the range of $300,000.

The Food and Drug Administration's clearance of Regius comes at a time of fierce competition between imaging firms that are bringing digital chest x-ray systems to market. In June, Oldelft of Delft, the Netherlands, announced FDA clearance for its Digidelca line of CCD-based digital chest systems, and Sterling Diagnostic Imaging of Greenville, SC, announced that its DirectRay system received approval (PNN 7/98). Last month, Danbury, CT-based Trex Medical's Continental division signed an exclusive agreement with Advanced Instrument Development X-Ray of Melrose Park, IL, to access the Imix 4000M digital system (see story, page 1). Companies such as Fuji and Philips have been marketing digital chest systems since the mid-1990s, and Swissray International of Hitzkirch, Switzerland, began selling its AddOn-Multi-System in the U.S. earlier this year.

In other Konica news, product marketing manager Thomas Nardozzi has left the company. Nardozzi handled a number of the firm's product lines, including Regius. Company executives declined to comment further on Nardozzi's departure.

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