Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

PreMD seeks to boost US market potential for skin cholesterol test:

This article was originally published in Clinica

Executive Summary

PreMD has filed a 510(k) marketing application with the US FDA to expanded the indications for its point-of-care (POC) skin cholesterol test Prevu(x), to include it use in assessing cardiovascular disease risk in individuals without known or suspected disease. "An expanded claim could dramatically increase the market potential of Prevu(x) POC," said Brent Norton, the Toronto, Canada firm's president and CEO. It would make the product "the first cost-effective, noninvasive test on the market to help assess carotid wall thickness and the presence of carotid plaques in patients without known coronary artery disease, cerebrovascular disease or peripheral artery disease", claimed the company. Carotid wall thickness and carotid plaques are established markers for future heart attacks and strokes. "Our discussions with potential marketing partners are advancing," said Dr Norton.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT048882

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel