Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for Iris. The designation comes about six months after the company achieved the first telerobotic stroke case using the robot, in which a neurosurgon in Panama treating a patient 120 miles away.
XCath officials think Iris could break down the geographic barriers to specialized stroke care by enabling physicians to remotely provide mechanical thrombectomy procedures.