Cerebral Oxygen Monitoring Device Approved
A new device designed and manufactured by OrNim Medical, Limited supports measurement of oxygen levels in the brain. The company recently announced receipt of marketing approval from the FDA, which was reported by Globes Online. The company also posted the FDA approval paperwork (pdf) on their website.
The system uses the company’s Ultrasound Tagged Light technology (UTLight). This transmits light beams through tissue. Light absorption by both deoxygenated and oxygenated hemoglobin is calculated. The light is tagged with ultrasound beams which allow superficial tissue to be bypassed. The method also enables a measurement of absolute oxygenation in the tissue that is being assessed.
The components of the device include three separate pieces: the bedside unit, monitor unit, and sensors. Both optics and electronics are required to support system functioning. The monitor provides an easy to read display of both current and historical data from the patient. Optic and electronic cables connect the monitor to the sensors. Sensors are easily attached to patient’s skin with adhesive.
To exemplify the process, oxygen-rich blood is red and will absorb more of tagged light. Areas that have poor oxygenation will reflect more light. This allows differentiation between oxygenation status based on the reflection calculated by the system.
Current methods to measure brain oxygenation are invasive and generally require placement of electrodes through the skull. The new product is primarily intended to support the emergency room, operating theaters, and critical care settings including patient transport.
The company is planning to procure additional approvals for the device in the future. The company also hopes to be able to use the system to asses muscles and kidneys; preliminary data suggests its utility for such. The device was originally created as a means to evaluate the oxygenation of fetuses.
March 24, 2008 Related topics: Product Approval & Certification, Monitoring, Diagnostic