On June 21, 2021, Sensome, a pioneer in connected medical devices, announced that its Clotild® Smart Guidewire System achieved the Breakthrough Device designation by the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). The revolutionary sensor technology uses machine learning algorithms to instantly identify biological tissues while turning invasive medical devices into connected healthcare devices.
Although ischemic stroke is a leading cause of long-term disability it can be treated by removing the clot blocking the brain blood vessel, but the clot needs to be removed as quickly as possible. Without knowing a clot’s unique characteristics, Clotild® Smart Guidewire System can remove the clot on the first attempt in one out of three cases. Its AI-powered tissue sensor provides physicians with critical information about the clot.
The FDA Breakthrough Devices Program is a voluntary program for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to help patients receive more timely access to breakthrough technologies and, in 2021, other breakthrough technologies have included batteries, implants, catheters, and ultrasound equipment. As part of this program, the FDA will provide Sensome with priority review and interactive communication on its path from device development to commercialization.
