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ClearPlan

This article was originally published in The Tan Sheet

Executive Summary

Fertility monitor distributed by Unipath Diagnostics reaches drug store shelves the week of March 1, retailing at $199.99 with a $25 introductory rebate. The handheld monitor, which tracks estrogen and luteinizing hormone levels in a woman's urine, cleared FDA Oct. 30 ("The Tan Sheet" Nov. 9, 1998, p. 13). FDA also signs off on a 510(k) Feb. 24 for the company's ClearPlan Data Transfer software that can download up to six months of fertility level and sexual event information from the monitor into a Windows-based format for review by a fertility specialist. The software, which is expected to be available in May through the company, should retail for approximately $100, Unipath says
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