ClotChip Earns FDA Breakthrough Device Designation

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ClotChip Earns FDA Breakthrough Device Designation


XaTek Inc. has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development ClotChip, marking a significant and distinguishing step in advancing the company's life-changing portable blood-clotting sensor toward commercialization. The FDA Breakthrough Devices Program was created in 2018 to expedite 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" over existing approved products.

ClotChip measures a patient's bleeding risk profile at bedside from a single drop of blood obtained from a fingerstick, much like a glucometer measures a patient's blood-glucose level. Such immediate notice can be a critical step in saving the life of someone who may otherwise die from excessive bleeding or clotting.

The team of researchers involved in the development, testing, and clinical trials of ClotChip include the following APT Center Investigators:

Full length original stories can be found at XaTek, PR Newswire, and Crain's Cleveland Business.