A non-invasive device for the accurate measurement of oxygen levels in the brain has been awarded US Food and Drug Administration (FDA) approval and is likely to change the face of oxygen monitoring during surgery, in the healthcare sector.
OrNim Medical Ltd. has proudly revealed that it has obtained FDA approval for its device for measuring oxygen levels in the brain, a critical measurement for patients with head trauma or undergoing general anesthesia during surgery. The current method for measuring cerebral oxygen levels is to insert electrodes through the skull, a procedure that OrNim’s device supersedes.
OrNim’s co-founders, CEO and CTO Dr Michal Balberg and President and Vice President of R&D, Dr Revital Shechter, had originally been seeking a way to measure oxygen levels in fetuses, but quickly realised the potential of the device for cerebral applications. It was also noted that the fetal market was too small for venture capitalists and the regulatory procedures for a fetal product were protracted.
Shechter explained, $quot;We sought a different sector where we could apply the same technology. We discovered a number of painful sectors. The first was measuring cerebral oxygen levels, but the product is also applicable for muscles and kidneys. When we become more established, we’ll return to the fetal market.$quot;
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