Nisonic P-100 and FAST-ICP: Non-Invasive ICP Assessment for Neuro-ICU and Emergency Teams

What the Nisonic P-100 is

The Nisonic P-100 is an off-the-shelf ultrasound system running the Nisonic FAST-ICP software. It combines a compact scanner trolley with a touch screen and AI computer, an ultrasound probe tailored for scanning and recording the optic nerve sheath diameter (ONSD), and the Nisonic ICP Scanner application for probe guidance and ICP readings.

The system received CE marking in May 2021, and the FAST-ICP software development was audited by a Notified Body for IEC 62304 and ISO 14971 compliance. Nisonic uses the P-100 for data collection in clinical studies and offers it in limited numbers to hospitals conducting ICP research.

How FAST-ICP works

FAST-ICP automatically analyses transorbital ultrasound images and applies Nisonic's patented methods to measure static and dynamic properties of the optic nerve sheath: the optic nerve sheath diameter and the Deformability Index. It guides probe positioning in real time and estimates image-derived biomarkers of raised ICP. An examination typically takes less than a minute and requires no equipment calibration.

The software is designed to be installed as an app on ultrasound scanners, including handheld devices, and on Windows-based computers. Using automated processing reduces dependence on the operator's manual caliper measurements, which is a recognised source of variability in ONSD ultrasound. For the clinical background see optic nerve sheath diameter and ICP.

Operators need only basic ocular ultrasound training, but consistent technique still matters. Because the software guides the probe and processes the image automatically, the intention is to reduce the variability that comes from manual caliper placement, and units should still audit their results.

Status: research use

FAST-ICP is currently labelled for research use only and is used in investigator-initiated studies in the USA, Europe and Africa. Nisonic is preparing to integrate it into established point-of-care ultrasound devices for Europe and the USA. A hospital buying a P-100 today should therefore treat it as a research tool and not as a replacement for standard clinical ICP monitoring.

Before ordering, confirm the intended use with the manufacturer, clarify what ethics approval or study protocol your institution needs, and check the registration requirements with the relevant UAE authority. We recommend that clinical decisions continue to rely on established methods.

In a research setting, define in advance what data will be recorded, how images are stored, and how results will be reported, so that the P-100 contributes usable evidence rather than isolated measurements.

Where non-invasive ICP assessment fits

Non-invasive tools are attractive where an invasive monitor is not available, not yet indicated, or carries risk: for example in emergency departments, in transport, or when screening patients before deciding on invasive monitoring. They complement rather than replace catheters and bolts, which remain the reference for continuous pressure and waveform data.

To compare approaches, read non-invasive ICP monitoring methods and invasive vs non-invasive ICP monitoring. A non-invasive ICP monitoring device is best viewed as a trend and screening aid in the right context.

• Neuro-ICU: adjunct for trend assessment when invasive access is limited
• Emergency department: rapid bedside screening
• Research units: protocol-driven data collection with automated measurement

Questions before purchase

Ask about availability, intended-use labelling, training of operators, software updates, data export, and the support Nisonic provides to research sites. Ask whether your institution qualifies under the programme for ICP research hospitals.

Also ask about data security: where images are stored, how patient data is protected and how the system connects to the hospital network.

Beckfinity can connect you with the manufacturer for the Nisonic range. Request information to discuss your research or clinical project.