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The Food and Drug Administration last month cleared—for the second time—Italian biomedical firm Esaote’s E-Scan MRI system. Although the agency originally approved the system last summer, the FDA requested another application when
The Food and Drug Administration last month clearedfor the second timeItalian biomedical firm Esaotes E-Scan MRI system. Although the agency originally approved the system last summer, the FDA requested another application when Genoa-based Esaote made what the FDA considered significant changes in the units gradient system during the final development stage.
E-Scan is an open-style MRI scanner dedicated to orthopedic studies, and includes a swiveling patient table between 0.2-tesla permanent magnets. Esaote supplies the unit to U.S. marketing partners Lunar of Madison, WI, and Siemens Medical Systems of Iselin, NJ (SCAN Special Report 1/99).
The agencys request for a second 510(k) application for E-Scan came as a surprise, according to Lunar, and delayed the products launch. Esaote had planned to ship the units in the first quarter of 1999, but since the second 510(k) application was submitted on March 23 and cleared on May 27, the companys commercialization calendar was interrupted. Although a Lunar spokesperson downplayed the effect of the delay, Lunars third quarter fiscal 1999 (end-March) results took a hit when the company couldnt recognize revenue for $2.7 million in E-Scan orders (SCAN 4/28/99).