Jan

2003

Lexicor Medical Technology Inc

Company: Lexicor Medical Technology Inc.
Product: DataLex Web portal
Date: 1/16/03

We are writing to you because on July 3 through 17, 2002, an investigator from the Food and Drug Administration (FDA) collected information that revealed a serious regulatory problem involving the product known as “DataLex” web portal which is made and marketed by your firm. This software product is promoted on Internet websites for DataLex and Lexicor, and uses data from your … to diagnose Attention Deficit Hyperactive Disorder (ADHD) in humans.

FDA District: Denver District Office

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Lexicor Medical Technology Inc

Amy Sellers

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