New Data Supports Broader Clearance For Skin Cholesterol Test, Maker Says
This article was originally published in The Gray Sheet
Executive Summary
Non-invasive diagnostic test maker PreMD says it has the necessary data to support broader use of its PREVU POC skin cholesterol test in asymptomatic patients
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PreMD Continues Appeals For Expanded Skin Cholesterol Test Indication
Toronto-based PreMD is exploring a formal scientific dispute against an FDA decision that its Prevu skin cholesterol test is "not substantially equivalent" to other markers of cardiovascular risk
PreMD Continues Appeals For Expanded Skin Cholesterol Test Indication
Toronto-based PreMD is exploring a formal scientific dispute against an FDA decision that its Prevu skin cholesterol test is "not substantially equivalent" to other markers of cardiovascular risk
PreMD cholesterol test
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...