Sensome’s Clotild AI-Powered Stroke Guidewire Receives FDA Breakthrough Device Designation

June 21, 2021—Sensome announced that it has been granted a Breakthrough Device designation by FDA for its Clotild smart guidewire system, which is designed to use artificial intelligence (AI) to improve the treatment of ischemic stroke patients.

The Clotild device integrates Sensome’s AI-powered tissue sensor, which enables the guidewire to provide critical information on the clot for physicians. The company’s sensing technology combines impedance-based microsensors with machine learning algorithms to instantly identify biological tissues with unequaled predictive reliability. The Clotild device is the first application of the technology.

Sensome noted that the FDA Breakthrough Device program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. As part of this program, the FDA will provide Sensome with priority review and interactive communication on its path from device development to commercialization.

“This is a tremendous recognition by FDA that will boost our efforts to bringing Clotild to patients in the United States,” commented Franz Bozsak, CEO and Cofounder of Sensome, in the company’s press release. “The first-in-human clinical trial of Clotild is expected to start later this year outside the United States, which will take our device one step closer to improving care for ischemic stroke patients around the world.”

Sensome is a spin-off from CNRS—France’s Centre National de la Recherche Scientifique—and Ecole Polytechnique in Paris, France.