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Home » Sensome Stroke Treatment Gets Breakthrough Device Status
Sensome Stroke Treatment Gets Breakthrough Device Status
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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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