The US Food and Drug Administration (FDA) has granted 510(k) clearance to PhysioSonics' cranial blood flow monitoring system.
The Presto 1000 Flow Monitor, which uses the company’s proprietary Flash Doppler, maintains the flow of information from mid cerebral arteries, without the need of a trained sonographer.
In addition, the monitoring system replaces periodic measurement with continuous monitoring.
PhysioSonics CEO Brad Harlow said the Presto 1000 also helps ICU and surgical patients by detecting abnormal changes in cerebral blood flow and alerting the attending nurse, bringing further institutional resources to diagnose the cause.
"These flow anomalies may be indicators of severe conditions such as vasospasm from aneurysm ruptures or head trauma, disturbances with brain auto-regulation, or MCA blood clots," Harlow added.
The company has also secured $1.05m from Series B add-on debt financing.