Philly company gets FDA approval for hand-held brain scanner

A Philadelphia company has won FDA approval for the first hand-held scanner to detect bleeding in the brain.

The scanner uses near-infrared light to detect in one to two minutes if there is blood pooling in the brain, or between the skull and the brain, and then sends the result to a PDA.

It is not designed to replace CT scans, which are the gold standard in detecting intracranial hematomas, but to help health-care professionals prioritize who needs care first.

“When the line to the CT scan is very long, it is critical that someone (with a probable hematoma) will be expedited and will bypass the whole long line and get that scan first,” said Baruch Ben Dor, CEO of InfraScan. “Time lost is brain lost.”

When checking for neurological injury, doctors ask patients questions and administer reflex tests, but the results can be ambiguous.

Larry Rodichok, a neurologist and medical reviewer at the FDA, said the scanner could help doctors spot hard-to-detect hematomas in patients whose neurological injuries are not apparent in routine exams.

“When that’s obvious then there isn’t much doubt about the need to act quickly,” Rodichok said. “For those who don’t have obvious clinical signs or who have confusing clinical signs, these kind of diagnostic devices are valuable.”

Bleeding in the brain can be deadly if not treated immediately.

Ben Dor started developing the device in 2004 after winning a Wharton business plan competition. The scanner has been on the market in Europe since 2008.

Much of the funding for the development of the device came from the U.S. military. InfraScan said NATO and U.S. forces are currently using the scanners in field hospitals in Afghanistan.

Eventually, they hope to get approval for use in ambulances.