PreMD's Prevu skin test for heart disease gets special 510(k) clearance

By Lisa Kerner

Charlotte, N.C., Sept. 20 - PreMD Inc. received special 510(k) clearance from the Food and Drug Administration for its second-generation spectrometer, or color reader, for the Prevu Point of Care (POC) Skin Sterol Test used to assess risk of heart disease by measuring cholesterol in skin tissue.

The new reader, developed in conjunction with Boehringer Ingelheim microParts GmbH, enables Prevu POC to operate in different health care settings.

PreMD Inc. is a predictive medicine company located in Toronto.

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