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PreMD cholesterol test

This article was originally published in The Gray Sheet

Executive Summary

Toronto-based PreMD files a 510(k) application seeking a broader claim for its Prevu POC noninvasive sterol test, the firm announces June 6. PreMD hopes the test, which measures cholesterol levels in the skin and was cleared in September for risk assessment of coronary artery disease in patients with a history of heart attack or evidence of artery blockage, will be cleared for patients without known or suspected disease. FDA is also reviewing a 510(k) application for Prevu LT, designed for use in the life insurance industry. Other cancer tests in development at PreMD include ColorectAlert, LungAlert and a breast cancer diagnostic...

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