PreMD submits Special 510(k) application to the FDA for new handheld Prevu reader

By Lisa Kerner

Charlotte, N.C., July 26 - PreMD Inc. submitted a special premarket notification, or Special 510(k), to the Food and Drug Administration for a second-generation spectrometer (color reader) for the Prevu Point of Care (POC) Skin Sterol Test for heart disease risk assessment.

A Special 510(k) is submitted for a modification to a device already cleared for marketing under the 510(k) process.

"This standalone, portable reader is designed to offer users greater flexibility," president and chief executive officer Brent Norton said in a company news release.

"We believe that these improvements will enhance the market appeal of Prevu POC."

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

PreMD said it has also submitted an amendment to its class II Medical Device License for Prevu POC to Health Canada's Therapeutic Products Directorate.

Prevu non-invasively measures the amount of cholesterol (sterol) that has accumulated in the skin tissues, as opposed to blood.

Toronto-based PreMD Inc. develops non-invasive tests for the early detection of life-threatening diseases.

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