EDAP International has suspended its U.S. marketing effort asit awaits Food and Drug Administration approval for renal andbiliary application of its lithotripter, according to AllisonDolphin, director of regulatory affairs for EDAP in the U.S. Robert
EDAP International has suspended its U.S. marketing effort asit awaits Food and Drug Administration approval for renal andbiliary application of its lithotripter, according to AllisonDolphin, director of regulatory affairs for EDAP in the U.S.
Robert Reeders, former general manager for EDAP's U.S. organization,has left the firm and no replacement has been hired. Olivier Missosse,president of the French company, officially heads up the U.S.operation as well, she said.
EDAP has moved its U.S. headquarters to: Five Sunny Knoll Terrace,Lexington, MA 02173 (phone: 617/674-2030). The firm will maintainits regulatory effort and service of lithotripters at clinicalsites. EDAP recently sent a revised premarket approval submissionto the FDA for renal applications, she said.
"The decision has been made that we will not make anymarketing efforts until we obtain PMA approval for the kidney,"Dolphin told SCAN. "Meanwhile, EDAP continues to maintaina strong position internationally. They have also put a lot ofeffort into research and development of new products."
Imlogix will supply more than 100 image display stations forthe ROI PACS, which will be used in stand-alone and multiscreenviewing configurations. The high-resolution displays will be offeredin 1000 x 1000-, 2000 x 2000- and 2000 x 3000-pixel configurations.
Genesys also integrates a Kodak optical disk storage systemand a Du Pont film digitizer in its PACS offering.
The agent will be targeted at computed tomography scanningof liver metastases. Initial studies indicate that the liposomeagent remains in the liver much longer than existing CT contrastagents, according to the U.S. company.
"They (Schering) are the world leader in developing andmarketing imaging contrast agents. They are the only company witha contrast agent field force that markets its products throughits own affiliates in all major pharmaceutical markets of theworld," said Charles A. Baker, chairman and CEO of Liposome.The firm estimates a potential worldwide market for improved CTliver imaging agents of as much as $700 million per year.
Hologic said increased R&D expenditures for its QDR-2000multi-beam densitometer also contributed to the loss. This unitis being tested at Hologic's facility in Waltham, MA. The companyhopes to begin shipments to outside beta sites shortly.
Despite the poor financial performance compared to last year,AFP's second quarter loss was two-thirds less than its first quarterloss and revenues increased by about $1 million from the firstto second quarters, the company said.