Ornim Medical Technology Wins FDA Approval

ornim.jpgIt used to be that the only way to measure oxygen saturation was to take a blood sample from an artery and analyze it in a lab, or to insert electrodes through the skull. The FDA, however, has just provided 510K approval to market a new technology called targeted oximetry that can measure oxygen saturation in the brain by using a noninvasive procedure that is less expensive and provides more immediate and accurate results.

OrNim’s Ultrasound Tagged Light technology (UTLight), according to Globes, “transmits a beam of light through tissue to measure the absorption of light by oxygenated and deoxygenated hemoglobin. The system tags the light with ultrasound beams enabling to bypass superficial tissue, and measure absolute oxygen saturation levels within the monitored tissue.”

ornim-also.jpgPresident and VP of R&D Dr. Revital Shechter: “If the blood in the area marked by the ultrasound is red and oxygen-rich, it absorbs more tagged light. If the area is light and oxygen-poor, more tagged light is reflected back to us. In this way, we can precisely measure oxygen levels.”

The measurement is critical for patients with head trauma or who are undergoing general anesthesia during surgery, but Shechter says the initial goal for the technology was to measure oxygen levels in fetuses. “The product is also applicable for muscles and kidneys,” she says. “When we become more established, we’ll return to the fetal market.”

Ornim was founded by Shechter and CEO and CTO Dr. Michal Balberg in 2004. They were initially financed by Davidi Gilo’s Gilo Ventures, a fund not generally known for biomedical investments. They are now seeking EU approval and plan to begin marketing there in 2009 aftter conducting some additional clinical studies.

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One Response

  1. 510K clearance on the Ultrasound Taged Light Technology will be of emmence use not only in head trauma patients but in patients where oxygen suply is in question. Targeted oximetry for measuring fetal oxygen levels is very promissing and a clinical need.

    Raj Nihalani, MD, RAC(US)
    Irvine, Ca

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