FDA slaps Bioptigen with warning over marketing claims

February 16, 2011 by MedCity News

Bioptigen receives a warning letter from the Food & Drug Administration that says the medical imaging firm is marketing its eye imaging scanner without proper regulatory approvals.

Bioptigen

Medical imaging technology company Bioptigen received a warning from the Food & Drug Administration alleging that the company is marketing its eye imaging scanner without proper approvals.

The Research Triangle Park, N.C.-based company makes a medical device that allows for imaging of the inner areas of the eye. The company has marketed the product for research as well as medical applications.

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