FDA delays clearance of POC Skin Cholesterol Test
The FDA has sent an NSE (non-substantially equivalent) letter to PreMD Inc. related to the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. “We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease,” the company said. The FDA has rejected the claim citing concerns over the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint.
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