Infrascan Brain Bleed Detector to Get FDA Approval in 2012
A handheld medical device designed to detect bleeding in the brain has been available for sale in Europe and chances are good that it gets approval from the U.S. Food and Drug Administration too. Developed by the Philadelphian Infrascan Co., the device spots the presence and location of brain bleeds up to two minutes based on differential near-infrared light absorption of a hematoma and normal brain tissue.
According to Medcitynews.com the device is designed to be used as a sort of triage device by first responders and physicians to assess whether patients need an urgent CAT Scan.
The company presented during the 2011 IMPACT Venture Summit in Philadelphia. Infrascan are awaiting regulatory approval from the U.S. Food and Drug Administration that CEO Baruch Ben Dor says should be coming within the next few months.
Ben Dor is an officer in the Israeli army and a physicist who moved to the U.S. in 2004. The company initially received a grant from the National Institutes of Health’s Small Business Innovation Research program that provides funding to commercially viable companies.
Ben Dor said the biggest challenge and frustration for his business is the FDA approval process. In Europe, the product is available for sale and estimated revenue from the device for 2011 are $650,000.
“We have been in a long protracted review process,” Ben Dor said. He said regulators are concerned that physicians will be too reliant on the Infrascanner and use it to the exclusion of performing CAT Scans.
Ben Dor said he also sees uses for the device for clinics in remote rural areas that may not have the resources of a healthcare provider in more populated areas.
The full story can be found on Medcitynews.com.