Nisonic
Trondheim, NO · 3 known investors
Nisonic develops FAST-ICP software that uses transorbital ultrasound imaging and machine learning to non-invasively detect raised intracranial pressure by measuring optic nerve sheath properties. The software is designed to run on standard and handheld ultrasound devices for use by clinicians and neurosurgeons treating brain injury and neurological conditions.
Also known as Nisonic AS
Investors · 3
Company profile
researched Aug 2026Nisonic AS is a medical software company headquartered in Trondheim, Norway, that develops products for non-invasive detection of raised intracranial pressure (ICP) using ultrasound imaging and machine learning. Its core product, the FAST-ICP software, automatically analyses transorbital ultrasound images and applies patented methods to measure static and dynamic properties of the optic nerve sheath — notably optic nerve sheath diameter (ONSD) and a Deformability Index (DI) — in order to estimate a patient's ICP. The examination is performed by placing an ultrasound transducer on the eyelid and typically takes less than a minute, with no equipment calibration required.
The software is designed to run on Windows-based computers and to be installed as an app in ultrasound scanners, including handheld point-of-care devices, giving real-time guidance for probe positioning and automated image processing and quantification. The company also offers the Nisonic P-100, an off-the-shelf ultrasound system running FAST-ICP that was CE-marked in May 2021 and is supplied in limited numbers to hospitals conducting ICP research. The clinical rationale is that ICP is otherwise measured invasively via a pressure sensor inserted through a cranial burr hole, a procedure that requires specialised personnel and carries cost and risks of infection and bleeding; traumatic brain injury alone affects nearly 70 million people annually worldwide.
As of the company's own account, FAST-ICP is designated research-only and is used in investigator-initiated clinical research in the USA, Europe and Africa, while the company prepares for market launch by installing FAST-ICP in established point-of-care ultrasound devices for Europe and the USA.
Founding story
The underlying method originated from collaboration between ultrasound engineers at the research institute SINTEF in Trondheim, Norway, and neurosurgeons at the Red Cross War Memorial Children's Hospital, University of Cape Town, South Africa. Ultrasound experts and neurosurgeons began working together in 2013 on concept and research, and Nisonic AS was established in 2017 in Trondheim as a spin-out co-founded by SINTEF and Cofounder. Key contributors named in company communications include neurosurgeon Dr. Llewellyn Padayachy (then at Red Cross War Memorial Children's Hospital, later Professor and Head of the Department of Neurosurgery, University of Pretoria, Steve Biko Academic Hospital), and SINTEF scientists Reidar Brekken and Tormod Selbekk, the latter becoming Nisonic's CTO.
Business model
Nisonic develops and licenses medical software intended to be installed as an application on third-party ultrasound consoles and handheld devices, and also supplies its own CE-marked Nisonic P-100 ultrasound system in limited numbers to hospitals conducting ICP research. The company's website invites ultrasound device manufacturers to host the FAST-ICP app on their consoles and clinicians to initiate research.
Traction
The Nisonic P-100 was CE-marked in May 2021 and is used for data collection in clinical studies. Clinical validation has been reported for detecting raised ICP in children, in adults with traumatic brain injury and in adults with aneurysmal subarachnoid haemorrhage, with multiple peer-reviewed publications. The company reports 200,000 collected ultrasound records from clinical studies, most with paired invasive ICP measurements.
Latest developments
In 2025 Nisonic reported publication of the first results from the subarachnoid haemorrhage study at Oslo University Hospital, Rikshospitalet, showing that automated ONSD measurement detects raised ICP with high sensitivity, particularly when excluding patients with prior surgical entry into the basal cisterns. The company launched a prototype refined AI model with additional image-based biomarkers for ICP quantification, reached 200,000 collected ultrasound records, is initiating and planning further studies in children and adults, and is preparing for market launch by installing FAST-ICP in established point-of-care ultrasound devices for Europe and the USA.
▸Full profile — market position, technology, go-to-market, geography, history, risks & controversies
Market position
Nisonic positions its technology as an alternative to invasive ICP monitoring via cranial burr hole. It states that its 2025 subarachnoid haemorrhage study is the first to demonstrate that optic nerve sheath diameter, automatically measured by FAST-ICP software, can be used as a non-invasive measure of raised ICP. It is listed among the portfolio companies of life-science investor Hadean Ventures.
The approach combines optic nerve sheath diameter with dynamic (deformability) properties of the nerve sheath rather than diameter alone, delivers fully automated measurement to reduce operator variability, and is delivered as software that can be installed on standard or handheld ultrasound consoles rather than as dedicated hardware.
Technology
FAST-ICP performs automated, real-time analysis of transorbital ultrasound images using machine-learning and deep-learning algorithms, estimating image-derived biomarkers of raised ICP including optic nerve sheath diameter and a Deformability Index reflecting pulsatile dynamics of the nerve sheath. The system provides real-time guidance for probe positioning and automated measurement to reduce operator variability, and a dedicated probe optimised for transorbital ultrasound has been designed. The company reports collecting 200,000 ultrasound records from clinical studies, most with associated invasive ICP measurements taken during the examinations, which are used to train neural networks; a refined AI model with additional image-based biomarkers has been launched as a prototype for retrospective and prospective studies.
Go-to-market
The company engages clinicians worldwide in investigator-initiated research to gather feedback and patient data, supplies the P-100 system to research hospitals, exhibits at trade fairs such as MEDICA, and is working with ultrasound device manufacturers to embed FAST-ICP in established point-of-care ultrasound devices ahead of a market launch in Europe and the USA.
Clinicians and neurosurgeons managing patients with traumatic brain injury, subarachnoid haemorrhage and other neurological conditions associated with raised intracranial pressure, in both paediatric and adult populations; hospitals conducting ICP research; and ultrasound device manufacturers seeking to add the FAST-ICP app to their consoles.
Geography
Headquartered in Trondheim, Norway, with clinical development at Oslo University Hospital (Ullevål and Rikshospitalet) and research origins linked to the University of Cape Town and, later, the University of Pretoria in South Africa. Investigator-initiated research using FAST-ICP is ongoing in the USA, Europe and Africa.
History
Between 2013 and 2015 the concept was developed by neurosurgeons and researchers in Norway and South Africa. In 2016-2018 the company pursued product design and proof of concept, with clinical studies, two publications, a patent application, a dedicated transducer design, a software prototype and industrial partnerships. In 2019-2020 a clinical study in adults with traumatic brain injury started at Oslo University Hospital Ullevål (halted during Covid) while the automated measurement methods were refined; the product was demonstrated at the MEDICA trade fair in Düsseldorf in November 2019. The Nisonic P-100 received CE marking in May 2021, and the FAST-ICP software development was audited by a Notified Body for compliance with IEC 62304 and ISO 14971 without findings. In 2023-2024 results from the TBI study were published in two clinical papers and a new study in adults with subarachnoid haemorrhage was initiated at Oslo University Hospital, Rikshospitalet. From 2025 the first SAH study results were published and the company has been developing a refined AI model and expanding clinical trials.
Risks & controversies
The FAST-ICP software is currently designated research-only and is used in investigator-initiated research rather than routine clinical care; the Nisonic P-100 is available only in limited numbers to research hospitals. A clinical study in adults with traumatic brain injury at Oslo University Hospital Ullevål was halted during the Covid period.
Compiled by commissioned research from 7 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
Timeline · 5
launches, deals, and filingsNisonic launched a prototype of a refined AI model with additional image-based biomarkers for quantification of ICP, for use in retrospective and prospective clinical studies.
A new clinical study in adults with subarachnoid haemorrhage was initiated in 2023 at Oslo University Hospital, Rikshospitalet.
The Nisonic P-100, an off-the-shelf ultrasound system running the Nisonic FAST-ICP software, was CE-marked in May 2021. The FAST-ICP software development was audited by a Notified Body for compliance with IEC 62304 and ISO 14971 without findings.
Nisonic demonstrated automatic measurements of optic nerve sheath diameter as a marker for increased intracranial pressure using transorbital ultrasound at the MEDICA trade fair in Düsseldorf, Germany, stating it was in the process of CE marking the product.
Nisonic started a clinical study in adults with traumatic brain injury at Oslo University Hospital Ullevål; the study was halted during Covid.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
In the news
▸Research sources · 7
primary sources listed
- Nisonicnisonic.com · web
7 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does Nisonic do?
- Norwegian medtech company whose FAST-ICP software uses transorbital ultrasound and machine learning to assess intracranial pressure.
- Who are Nisonic's investors?
- Nisonic's investors include Hadean Ventures, Sarsia Management AS, Investinor.
- Where is Nisonic headquartered?
- Nisonic is headquartered in Trondheim, NO.