PhysioSonics, a Bellevue, Washington company, received a U.S. Army grant to upgrade its cerebral blood flow monitor to be able to detect intracranial vasospasms, a dangerous consequence of traumatic brain injuries (TBI) that can lead to reduced blood flow in the brain.
The company’s blood flow monitor uses ultrasound to automatically lock on to the hemodynamics of the cerebral artery and so does not require a sonographer to operate the device. The military plans on reviewing the monitor once it is approved by the FDA.
More from the press release:
“PhysioSonics has developed a simple to use, portable monitor that can automatically identify the mid-cerebral artery and provide a continuous read of the blood’s flow and peak velocity,” said Brad Harlow, CEO of PhysioSonics. “This is essential for diagnosing and monitoring vasospasm. Transcranial Doppler ultrasound – the current technology standard – relies on highly trained medical personnel and is therefore too awkward and expensive to be deployed near combat, or even at high volume military hospitals. We believe that our blood flow monitor, adapted for the rigors of military use, can help clinicians accurately monitor for vasospasm among soldiers injured by a blast, from an improvised explosive device, a land mine, or another traumatic explosion.”
Use of PhysioSonics’ cerebral blood flow device for detecting vasospasm is investigational and not an approved use in the United States. The company recently completed a clinical study of its blood flow monitor that showed parity with transcranial Doppler ultrasound. It intends to file a 510k application for the blood-flow monitor with the U.S. Food and Drug Administration.
Upon commercialization, the company intends to sell the device and disposables to hospitals with neurosurgery and cardiac surgery suites in the U.S. It will later submit a pre-market approval application to the FDA to add a non-invasive intracranial pressure monitoring indication to the device.