FDA clears Sonosite’s hand-held ultrasound

SonoSite of Bothell, WA, this month received premarket clearance for its digital hand-held ultrasound unit. The company announced April 5 that the Food and Drug Administration had cleared the device and that SonoSite would begin its marketing efforts.

Last May, SonoSite’s prototype device received premarket clearance, which covered 11 clinical applications including obstetrical, gynecological, abdominal, and cardiovascular imaging (SCAN 5/13/98). The new clearance covers such updates to the prototype as increased signal processing ability, and adds transrectal imaging to the device’s list of applications. SonoSite’s scanner will weigh less than 6 pounds and the firm expects to begin selling the units late this year.

The company moved quickly to establish distributor partnerships for the unit, announcing April 7 that it had signed an agreement with Esaote of Genoa, Italy. The agreement gives Esaote distribution rights for the new device in Germany, France, Italy, and the Netherlands.