Need for a simpler method for ICP measurement
Several neurological conditions are associated with raised intracranial pressure. Traumatic Brain Injury alone affects nearly 70 million people each year worldwide. Today ICP is measured invasively by inserting a pressure sensor through a cranial burr hole. The invasive procedure is performed by highly specialized personnel and carries along a high cost and risk of infection and bleeding. Early diagnostics and treatment is important. Nisonic has developed the technology to enable non-invasive detection of increased intracranial pressure.
Ultrasound imaging for non-invasive detection of ICP
Nisonic has developed the FAST ICP software for automated analysis of transorbital ultrasound images, implementing novel and patented methods for measuring the static and dynamic properties of the optic nerve sheath to predict the patient’s intracranial pressure. The method has been developed by engineers at SINTEF, Trondheim, Norway and neurosurgeons at Red Cross War Memorial Children’s Hospital, University of Cape Town in South Africa.
The Nisonic FAST-ICP software is estimating image-derived biomarkers for raised ICP in real-time. The software can be installed in Windows based computers and in ultrasound devices. The unique FAST-ICP software has the potential to transform any standard medical ultrasound console to a device that can predict the intracranial pressure. To allow for non-invasive measurement of ICP, the user simply performs an transorbital ultrasound examination, which typically takes less than a minute.
The Fast-ICP software provides real-time guiding to simplify image acquisition, and performs automated AI-based image processing and quantification of multiple parameters to predict the patients ICP. The Nisonic methods has been clinically validated to detect raised ICP in children, adults with traumatic brain injuries and in adults with Aneurysmal Subarachnoid Hemorrhage.
Fast and simple
Ultrasound imaging can be completed within a minute
No equipment calibration.
Easy to use
Guided probe positioning.
Automatic measurement.
Better patient care
Enables earlier treatment.
Reduced invasive interventions.
Saves time and cost.
The Company
Nisonic AS is a medical software company developing products for non-invasive detection of intracranial pressure (ICP) using ultrasound imaging and machine learning. The company was established in 2017 in Trondheim, Norway. Ultrasound experts and neurosurgeons have been working together since 2013 combining world leading ultrasound technology with clinical expertise to develop the new method for detecting intracranial pressure.
Our timeline
2013-2015
Research & concept
Concept developed by neurosurgeons and researchers in Norway and South Africa
2016-2018
Product design/Proof of concept
Clinical studies / 2 publications
Pulsatile Dynamics of the Optic Nerve Sheath and Intracranial Pressure: An Exploratory In Vivo Investigation
Noninvasive Transorbital Assessment of the Optic Nerve Sheath in Children: Relationship Between Optic Nerve Sheath Diameter, Deformability Index, and Intracranial Pressure
Patent application filed
Dedicated transducer design
Software prototype
Industrial partnerships
2019-2020
Development/Clinical trial
Started clinical study at Oslo University Hospital Ullevål (halted during Covid) in adults with Traumatic Brain Injury.
Continuous refinement of the automated measurement methods in the FAST-ICP software.
2021
First CE-marked product
Nisonic P-100 CE-marked May 2021 – Off the shelf ultrasound system running the Nisonic FAST-ICP software. It proves that the Nisonic software is able to perform image acquisition guidance and automated image processing in real time when installed on a ultrasound device.
The FAST-ICP software development was audited by Notified Body with respect to compliance with IEC 62304 and ISO 14971, without any findings. The Nisonic P-100 ultrasound device is used for data collection in clinical studies.
2023-2024
Publication of results in TBI study - initiation of new study
The results of the FAST-ICP processing in TBI patients resulted in two clinical papers. The results of the clinical trial shows that it is possible to differentiate low and high ICP by using the Nisonic methods to estimate optic nerve sheath diameter ONSD and the dynamics of the optic nerve sheath as expressed by the Deformability Index (DI).
Important papers, as it shows that the results obtained in children are replicated in an adult patient population.
New study initiated in 2023 at Oslo University Hospital, Rikshospitalet, in adults with subarachnoid hemorrhage (SAH).
2025 -
New clinical paper, new AI developments, expanding clinical trials
The first results of the SAH study published, demonstrating that the automated measurements of ONSD can detect the condition of raised ICP with high sensitivity, and in particular when excluding patients that have had surgical entry into the basal cisterns prior to the measurements.
It is the first study in the world that demonstrates that the optic nerve sheath diameter as automatically measured by the Nisonic FAST-ICP software can be used as a non-invasive measure raised ICP.
New studies are being initiated and planned, involving indications in children and in adults.
Nisonic reaches a milestone when it comes to number of ultrasound images collected from clinical studies: 200 000 records, most of them having associated invasive ICP measurement registered during the ultrasound examinations.
The images are used for training of neural networks (deep learning), and Nisonic is training a new refined AI-model with additional image based biomarkers for quantification of ICP. The prototype model has been launched and is to be used in retrospective and prospective clinical studies.
Preparing for market launch: Installing the FAST-ICP in established Point of Care Ultrasound devices for use in Europe and USA.
Our product
- The FAST-ICP software is intended to be installed as an App in ultrasound scanners including handheld ultrasound devices, and offers:
Guidance for probe positioning during transorbital ultrasound imaging
Automatic measurements based on advanced machine-learning algorithms
The FAST-ICP Software is currently research only and is being used in ongoing clinical investigator initiated research in USA, Europe and Africa. The AI based processing is currently being evaluated for a wide range of indications in children and in adults.
The Nisonic P-100 ultrasound system is available in a limited number for hospitals doing research on ICP.
Do you want to know more about Nisonic and FAST ICP? If you are an clinician interested in initiating research, a ultrasound device manufacturer interested in having the FAST-ICP app on your console or simply want to invest in the next global standard for non-invasive ICP measurements – please contact Nisonic AS by sending an email.
Contact us
Our team
We are an interdisciplinary and experienced team in the intersection of technology and healthcare.
With leading competence within ultrasound technology we are collaborating closely with international neurosurgeons, clinicians and research institutes to enable better diagnostics and treatment.
Would you like to join our team?
Please send your CV and motivation to contact@nisonic.com
Our advisory board
Llewellyn Padayachy
Steve Biko Academic Hospital
Llewellyn (Chairman of SAB) is a neurosurgeon, currently serving as professor and head at the University of Pretoria, Steve Biko Academic Hospital, Pretoria, South Africa. He is primarily a pediatric neurosurgeon with special interests in non-invasive diagnostic and minimally invasive surgical techniques and serves on the executive committees various international and local neurosurgical organisations. He has over a decade developed novel non-invasive diagnostic methods using ultrasound-based parameters for detection of ICP.
Eirik Helseth
MD, University of Bergen in 1985. PhD, University of Trondheim 1988. Postdoc at Dana Farber Cancer Institute, Harvard University in Boston 1988/1989. Board certified Neurosurgeon in 1996. Appointed professor in Neurosurgery, University of Oslo in 2004. Professor Helseth is an experienced neurosurgeon and researcher with special interest in brain tumors and neurotrauma.
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