Product Launch Q4 / 2026

Transforming ultrasound signals into insight

Our device delivers fast, safe, and cost-effective decision support for traumatic brain injury – without the risks of invasive procedures.

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The technology behind our non-invasive ICP assessment

Quantifiable results that demonstrate the power of intelligent medical software
Transmission ultrasound
We turn ultrasound signals into meaningful intracranial pressure insight – without entering the skull. Our device represents a new era in brain monitoring, avoiding the need for invasive probes when assessment of elevated intracranial pressure is indicated. Using transmission ultrasound, it detects the movements of the skull and the dynamic changes within the brain’s three compartments: brain tissue, blood, and cerebrospinal fluid (CSF).

From raw signal to brain pulse curve
The signal relies purely on one physical parameter: the time of flight of the ultrasound signal. Based on this raw data, our technology generates a precise pulse curve that reflects the natural pulsation of the brain.
AI-powered classification
During development, an AI-based algorithm – our classifier – was trained and validated on extensive clinical study data to recognize subtle pulse patterns linked to normal or elevated intracranial pressure. Once released for clinical use, the classifier applies these validated features to patient data, providing a reliable, real-time assessment of intracranial pressure – without any further AI processing or learning in the field.

Smart technology
For the first time, brain pressure can be measured completely non-invasively, and in real time without any risk or discomfort for the patient.
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Product Launch Q4 / 2026

Smart. Compact. Easy to Use.

A stand-alone device for non-invasive intracranial pressure (ICP) assessment
Our device provides real-time, non-invasive results, if intracranial pressure is elevated or normal – without the need for invasive probes or additional monitoring systems.

It captures and analyzes ultrasound-based signals through a clinically validated and released algorithm, delivering consistent and clinically relevant information at the bedside.

Designed as a compact, stand-alone solution, it integrates seamlessly into existing clinical workflows.
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Clinical Study

A multicenter clinical study is currently underway across 13 hospitals to evaluate our non-invasive approach to intracranial pressure assessment in patients with traumatic brain injury (TBI).

The study is conducted in accordance with the European Medical Device Regulation (MDR) and aims to demonstrate the performance, safety, and clinical value of the technology for avoiding unnecessary invasive probes.

Completion is expected in January 2026, providing the clinical evidence base for CE marking anticipated in Q4/2026.

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Economic Impact – better care, lower costs

Invasive intracranial pressure monitoring is a complex and costly procedure that can only be performed in a limited number of hospitals.

Each probe placement involves surgical effort, ICU capacity, and potential complications, adding an estimated USD 3,000–4,000 in hospitalization costs per patient.
Clinical data suggest that up to 50 percent of invasive probes are ultimately avoidable, exposing patients to risks and hospitals to additional costs.

By avoiding unnecessary invasive probes in patients with traumatic brain injury, our non-invasive approach can help reduce procedural and complication-related costs while optimizing the use of intensive care resources.
This targeted improvement addresses a significant clinical and economic inefficiency in today's neurocritical care.
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Frequently Asked Questions

Today, assessing intracranial pressure often requires placing an invasive probe inside the skull, which carries risk and therefore is typically reserved for only the most severe cases. As a result, many patients who could benefit from earlier intracranial pressure assessment are not assessed at all.

The device is in advanced clinical validation and progressing through the evidence generation required for CE marking under MDR. Completion of the pivotal study is expected in January 2026, in alignment with European and internationally recognized regulatory standards.

We expect CE marking in Q4 2026.

AI is used during development to build and validate the model. Once released, the product operates with a fixed, validated algorithm, no adaptive AI at the bedside

We start with one clearly defined first use case, but the potential of non-invasive intracranial pressure assessment goes far beyond. Our goal is to build a new category in brain diagnostics and to expand step by step into additional neurological and emergency-care applications, where fast, safe brain assessment can change clinical decisions and outcomes.

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If you have further questions, please don't hesitate to get in touch with us.
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Revolution of ICP
AI-driven brain diagnostics you can trust. Making brain monitoring simple, fast, and clinically meaningful.
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