XaTek Inc. receives key FDA designation to aid commercialization of its ClotChip device


XaTek Inc., a clinical-stage diagnostic device company based in Cleveland, said it has received Breakthrough Device designation from the U.S. Food and Drug Administration for its ClotChip technology.

The designation represents “a significant and distinguishing step in advancing” the portable blood-clotting sensor toward commercialization, XaTek said in a news release issued Tuesday, March 3. The FDA created the Breakthrough Devices Program in 2018 to speed up the development, assessment and review of technologies that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.”

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Story excerpt provided by Crain’s Cleveland Business.

Written by Scott Suttell.

Originally published March 3, 2020.

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