Seattle area start-up PhysioSonics just announced receiving FDA 510(k) clearance for its Presto 1000 Flow Monitor, a device that allows any clinician to perform cranial blood flow monitoring without requiring the services of a professional sonographer.
The system features proprietary auto-locating technology that allows users to easily locate and keep the ultrasound beam focused on the cerebral artery. The company is hoping that future approvals will lead to the technology being used for emboli detection and non-invasive intracranial pressure monitoring.
From the press release:
The Presto 1000 Flow Monitor is designed to allow any clinician to perform mid cerebral cranial blood flow monitoring, freeing institutions to more efficiently deploy sonographers who are required less often for the system. It is also designed to replace periodic measurement with continuous monitoring.
“The Presto 1000 Flow Monitor will help with 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.” said Brad Harlow, CEO of PhysioSonics.
PhysioSonics uses its proprietary “Flash” Doppler for the monitoring functions. The addition of Flash, with the transducers attached to headset, assists in locating and maintaining the flow of information from mid cerebral arteries.