AMBU EXPANDS NEUROLOGY PORTFOLIO IN NORTH AMERICA AND EUROPE

Copenhagen, Denmark, 20 August 2026 – Ambu, the global leader in single-use endoscopy, today announces 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European regulatory clearance (CE marking) for its new Ambu Neuroline Cup MRI/CT solution, expanding its neurology offering.

Ambu’s Neuroline Cup MRI/CT EEG solution is designed to support continuous brain activity monitoring for critically ill patients who need to undergo MRI or CT scans. This is particularly relevant in intensive care units (ICUs), where patients suffering from critical conditions often require continuous, long-term monitoring.

The Ambu Neuroline Cup MRI/CT solution consists of:

• Ambu Neuroline Cup MRI/CT: MR-conditional cup electrodes to be placed on the patient’s head during brain activity monitoring.
• Ambu Neuroline EEG Harness: Extension cable that connects the single-use electrodes to hospitals’ existing EEG monitoring systems.

In clinical practice today, electroencephalogram (EEG) monitoring is typically interrupted during imaging if MR-conditional electrodes are not used, as standard electrodes and cables are not compatible with the magnetic conditions of MRI or CT environments. Removal before scanning and reapplication afterward lead to longer interruptions of patient monitoring and unreliable diagnostics, posing potential risks to patient safety and inefficient use of staff resources.

By using materials designed for MRI and CT environments, Ambu’s new solution allows the electrodes to remain on the patient during imaging, supporting uninterrupted monitoring and more reliable data for clinical decision-making.

The Neuroline Cup MRI/CT solution further strengthens Ambu’s broad neurology portfolio and supports the company’s long-term growth expectations of 3-5% in Anesthesia & Patient Monitoring. The U.S. market for MR-conditional EEG electrodes is estimated at approximately DKK 300 million in 2026 and is expected to grow by approximately 19% annually through 2030, making it Ambu’s largest market for MR-conditional EEG electrodes.

The company will launch the new solution in both the U.S. and Europe in the fall of 2026.

“For 50 years, Ambu has been a trusted partner in patient monitoring, delivering reliable, high-quality electrode solutions to clinicians worldwide,” says Britt Meelby Jensen, CEO of Ambu. “With our Neuroline Cup MRI/CT solution, we support uninterrupted brain activity monitoring, delivering consistent, high-quality diagnostics, improved efficiency, and better patient outcomes.”