This article was originally published in The Gray Sheet
Executive SummaryReceives 510(k) clearance for its handheld ultrasound imaging device May 8 covering 11 clinical applications including obstetrical, gynecological, abdominal and cardiovascular imaging. The company, spun off from ATL Ultrasound on April 6 ("The Gray Sheet" May 11, p. 23), plans to introduce the product initially in the women's health care market in the second half of 1999 pending finalization of product design, the firm explains. Battery-powered and weighing under 10 pounds, the device is expected to sell for under $20,000...
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