FDA determines Celliant products meet criteria as medical devices

By August 25, 2017 October 17th, 2018 Featured

Hologenix, maker of the Celliant clinically tested responsive textile technology, said that the US Food and Drug Administration (FDA) has determined Celliant products are medical devices and general wellness products, as defined in Section 201(h) of the Federal Food, Drug and, Cosmetic Act.

According to the FDA, Celliant products were determined to be medical devices because they temporarily promote increased local blood flow at the site of application in healthy individuals.

“Celliant-engineered products are the first of their kind that the FDA has designated as medical devices,” said Seth Casden, Hologenix CEO.