Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices and Radiological Health of the FDA for its Clotild Smart Guidewire System designed to improve the treatment of ischaemic stroke patients.
Acute ischaemic stroke, a leading cause of long-term disability, can be treated by removing the clot blocking the brain blood vessel using mechanical thrombectomy devices, which are guided from the groin over a wire to the blockage. To improve patient prognosis, the clot needs to be removed as fast as possible.
Today, without knowledge of the clot’s characteristics, the clot can only be removed on the first attempt in one out of three cases. Clotild Smart Guidewire System integrating Sensome’s AI powered tissue sensor enables the guidewire to provide physicians with critical information on the clot.
