Neural Analytics, a medical robotics company, has enrolled the first subjects in its next-generation robotic platform as part of the IRB-approved CODEX study of Lucid M1 Transcranial Doppler Ultrasound System and NeuralBot System (Lucid Robotic System).
CODEX study is a prospective, single-arm, multi-centre, safety and technical feasibility study evaluating the investigational device exemption (IDE) version of the System. The study will be conducted at the Ochsner Clinical Foundation in New Orleans, Louisiana, US.
Ochsner Clinical Foundation neurocritical care and stroke assistant professor Ifeanyi Iwuchukwu said: “We are honored to be the first in the world to evaluate the performance of Neural Analytics’ next-generation robotic technology. So far, we have been impressed with the improved simplicity, and ease of use of the new Lucid Robotic System.
“Over the past nine months we have generated a tremendous amount of data to support the use of the Lucid Robotic System in the management of patients suffering stroke and we are excited to be building upon that with this next generation platform.”
Lucid Robotic System serves as an adjunct to standard clinical practices
The company said that its Lucid Robotic System is a medical ultrasound device designed for measuring and displaying cerebral blood flow velocities (CBFV) and the occurrence of transient emboli within the brain, but not intended to replace other means of evaluating vital patient physiological processes.
Neural Analytics said that the IDE version of the technology is intended to improve performance and further assist physicians in the management of patients suspected of suffering stroke.
Following the FDA approval of the first generation Lucid Robotic System in 2018, Iwuchukwu and the Ochsner Clinical Foundation have been using the investigational version of the device for the CODEX Study.
In addition, the study is aimed at exploring the technical feasibilities in wide range of patients and neurological pathologies to make monitoring of CBFV easy for stroke clinicians.
