PhysioSonics

February 1, 2013 — PhysioSonics announced the U.S. Food and Drug Administration (FDA) has granted the Presto 1000 flow monitor system 510(k) clearance for cranial blood flow monitoring. In addition, the company announced completion of Series B add-on debt financing, closing with $1.05 million.

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.

The company has 33 U.S. and foreign patents covering its technology. It has been the recipient of DARPA and NIH funding to use PhysioSonics technology to study head trauma, traumatic brain injury and bi-lateral flow monitoring.

PhysioSonics has developed a non-invasive, long-term cerebral blood flow (CBF) Platform. Utilizing novel ultrasound technology, the company has developed a new method that enables the device to locate and hold on the cerebral artery without a trained sonographer. This auto-locating ultrasound technology thus enables an easy-to-use method for the continuous monitoring of CBF. Future uses of this platform may include emboli detection and non-invasive intracranial pressure monitoring, both of which will require additional FDA submissions.


Related Content

News | Point-of-Care Ultrasound (POCUS)

June 17, 2025 — Royal Philips has announced the global launch of the Flash Ultrasound System 5100 POC — a new point-of ...

Time June 19, 2025
arrow
News | Lung Imaging

June 18, 2025 — Exo recently announced that now included on its Exo Iris is the first ever FDA 510(k) cleared AI for ...

Time June 18, 2025
arrow
News | Artificial Intelligence

April 16, 2025 — An artificial intelligence (AI) program trained to review images from a common medical test can detect ...

Time April 16, 2025
arrow
News | Ultrasound Women's Health

April 11, 2025 — Contrast-enhanced ultrasound (CEUS) is a safe and accurate diagnostic imaging option for pregnant women ...

Time April 11, 2025
arrow
News | Focused Ultrasound Therapy

March 31, 2025 — Neuropathic pain affects up to 10 percent of the global population and can be challenging to manage ...

Time April 02, 2025
arrow
News | Breast Imaging

March 20, 2025 — GE HealthCare has launched Invenia Automated Breast Ultrasound (ABUS) Premium, the latest 3D ultrasound ...

Time March 21, 2025
arrow
News | X-Ray

March 18, 2025 — GE HealthCare recently announced a collaboration with NVIDIA expanding the existing relationship ...

Time March 19, 2025
arrow
News | Breast Imaging

Feb. 26, 2025 — iCAD, Inc. a provider of clinically proven AI-powered cancer detection solutions, and Koios Medical, a ...

Time March 03, 2025
arrow
News | Focused Ultrasound Therapy

Jan. 8, 2025 - EDAP TMS SA, a supplier of robotic energy-based therapies, has announced that the first patient has been ...

Time January 08, 2025
arrow
News | Radiology Business

July 19, 2024 — GE HealthCare announced it has entered into an agreement to acquire Intelligent Ultrasound Group PLC’s ...

Time July 19, 2024
arrow
Subscribe Now