PhysioSonics received FDA 510(k) clearance for the Presto 1000 Flow Monitor. The Presto 1000 is used for ultrasound cranial monitoring, particularly in ICU or operating room patients who require mid-cerebral cranial blood flow monitoring. This new device replaces periodic blood flow testing with continuous blood flow monitoring and is designed to provide better patient outcomes in cases where cranial blood flow interruptions could signal an impending aneurysm or other serious problem. One additional advantage of the Presto 1000 is that it does not require a sonographer to monitor and operate it, allowing the medical facility to use its scarce sonographers more effectively. The Presto 1000 Flow Monitor utilizes Flash Doppler sonography, a PhysioSonics proprietary method for non-invasive blood flow monitoring that automatically identifies and monitors the cerebral artery.

PhysioSonics suggested it intends to petition in the future for additional FDA clearance to use the technology to monitor intracranial pressure and potential embolisms.

PhysioSonics also announced closing it’s series-B financing for $1.05 million. In the past, the company received grants from DARPA and NIH.

References
http://www.marketwatch.com/story/physiosonics-announces-fda-clearance-fo...