NightWatch+ US, a Breakthrough Seizure Monitor for epilepsy patients, receives FDA clearance.
Leiden, The Netherlands – 28-08-2025 – LivAssured BV today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a U.S. version of the NightWatch+, the company’s clinically validated wearable system for nocturnal epileptic seizure detection. This clearance paves the way for NightWatch+ to be made available to people with epilepsy and their caregivers across the United States.
NightWatch+ US is worn on the upper arm and continuously tracks heart rate and motion during sleep. Using advanced algorithms, it detects major motor nocturnal epileptic seizures such as tonic-clonic (TC), tonic (>30 seconds), hyperkinetic and TC-like seizures with high sensitivity. When a potentially dangerous seizure is detected, a warning is transmitted via a wireless signal from the sensor to the corresponding alarm station to notify a caregiver. A connecting data platform tracks long-term nocturnal seizure activity over time. Clinical studies in leading epilepsy centers have demonstrated high accuracy in the detection of severe nocturnal seizures, and doing so reduces stress levels in caregivers.
NightWatch+ US is the first FDA-cleared seizure detection device that is cleared for use in children as young as 4 years old. Moreover, it detects a broader range of epileptic motor seizures. And, it is the first FDA epileptic seizure monitor that functions stand-alone and does not need a continuous, stable mobile phone connection to alarm caregivers. Last but not least, it does not require a paid subscription to function.
“FDA clearance is a major milestone for LivAssured and an important step for the epilepsy community in the U.S.,” said Jeroen van den Hout, CEO of LivAssured BV. “NightWatch has already proven its impact in Europe, where thousands of families rely on it every night. With this clearance, we can now bring the same quality of care to epilepsy patients and caregivers in the United States.”
NightWatch has been widely adopted in Europe, where it is being recommended by leading neurologists and epilepsy associations. With FDA 510(k) clearance, LivAssured will start shipping NightWatch+ US as a prescription device starting early 2026. The company is actively working with US-based healthcare providers, epilepsy centers, and patient organizations to ensure broad access.
About LivAssured:
LivAssured BV is a Dutch medical technology company dedicated to improving the safety and quality of life of people with epilepsy and their caregivers. By combining clinical research, advanced technology, and patient-driven design, LivAssured develops innovative solutions for long-term epilepsy monitoring.