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Italian PACS firm plans entry into U.S.An Italian PACS developer has filed a 510(k) application with the Food and Drug Administration in preparation for U.S. sales of its product line. The company, Program S.r.l. of Vicenza, has also signed a
An Italian PACS developer has filed a 510(k) application with the Food and Drug Administration in preparation for U.S. sales of its product line. The company, Program S.r.l. of Vicenza, has also signed a letter of intent with a U.S. company for exclusive distribution rights in the U.S. and Canada.
Program was established in 1994 and has a dominant share of the PACS market in Italy, where it installed its first beta site three years ago. Program's products are also marketed in Germany, Switzerland, and Austria, and the company recently signed on Duncan Hynd Associates (DHA) for distribution in the U.K. and Ireland.
Program's MedStation PACS line is based on the Windows NT operating system, and company representatives compare it to offerings from Rogan, Applicare, Cemax-Icon, and CompuRad. One differentiating feature of MedStation, however, is its ability to conduct maximum intensity projection (MIP) image-fusion display, in which an image from one modality, such as CT, is overlaid on that from another, like MRI. The technique is often used for applications such as radiation treatment planning.
In addition to filing the 510(k) application for MedStation last month, Program is in discussions with Service Support Group (SSG) of Seattle for exclusive North American distribution rights. SSG is an equipment service and asset management company that is interested in entering the market for healthcare information technology. Program hopes to have clearance for MedStation by this year's Radiological Society of North America meeting.