XaTek has has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development ClotChip.
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.
John Zak, co-founder and CEO of XaTek, said: "I'm tremendously proud of the entire XaTek team and their remarkable efforts, which lead the FDA to believe ClotChip indeed satisfies all of the criteria for Breakthrough Devices Designation for the proposed indication for use. Once commercially available, this device will fulfil a critical and unmet clinical need for the newer generation of drug therapies known as 'direct oral anti-coagulants' – for which there is no point-of-care test available today."
XaTek intends to pursue additional indications for use in the near future, potentially including patients on other anti-coagulant therapies, those with haemophilia and other rare bleeding conditions and those with trauma-related indications.
