Breakthrough Status

Sensome Stroke Treatment Gets Breakthrough Device Status

June 24, 2021

Paris-based devicemaker Sensome’s Clotild Smart Guidewire System for ischemic stroke patients has been granted a Breakthrough Device designation by the FDA.

The guidewire system uses an artificial intelligence-powered tissue sensor that gives physicians critical information about the clot that caused the patient’s stroke.

The first-in-human clinical trial of the system is expected to start later this year, according to Sensome’s CEO Franz Bozsak.

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