The FDA granted approval for the infrascanner to be marketed through a de novo classification process, a regulatory pathway for some low-to-moderate-risk medical devices that are not comparable to a legally marketed device, according to a press statement.
The infrascanner 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. Its portable brain diagnostic device called ’MindReader’ acquires EEG data wirelessly and can be used on an Android phone.
Baruch Ben Dor, CEO of the Doylestown, Pennsylvania company, initially received a grant from the National Institutes of Health’s Small Business Innovation Research program that provides funding to commercially viable companies. It signed a $2 million contract with the U.S. Marine Corp. and U.S. Navy in 2010. Four of its systems are currently being used in the Helmand Province of Afghanistan.
Frustrated with the pace of the FDA approval process, Ben Dor enlisted the help of U.S. senators for Pennsylvania Robert P. Casey and Pat Toomey, and U.S. Rep. Allyson Schwartz earlier this year to help expedite the process.
The company pitched to potential investors at the 2011 IMPACT Venture Summit in Philadelphia last month to raise money to market the device in Europe where the infrascanner has been available.
The Centers for Disease Control and Prevention reports that 1.7 million people suffer traumatic brain injury each year.