Zeto, which makes brainwave monitors for emergency rooms, received a third FDA clearance for an EEG device. The latest is intended for use in outpatient clinics or at home.
Dubbed the New Wave, the device is designed to capture short-term recordings of up to 2.5 hours using a 21 soft-tip electrode headset paired with a compact recorder. The system collects synchronized video and audio, along with optional signals such as ECG, EOG and EMG, as well as other brain health metrics, the company said in an April 2 press release.
The device’s portability is intended to address a persistent issue in the U.S., where patients can wait weeks for an EEG appointment due to a shortage of EEG technologists, delaying follow-up care, the company said.
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“We listened to neurologists’ needs and designed a system that helps clinics expand access to EEG, address staffing challenges and improve the patient experience,” Florian Strelzyk, Zeto’s chief executive, said in the release.
The company debuted its ONE system, designed for ICUs, emergency departments and patient transport, two years ago. Both New Wave and ONE operate on a cloud platform that allows remote access.
Zeto’s other FDA-cleared EEG device is the WR19.
In January, Naox Technologies received FDA clearance for what it described as the first in-ear EEG device, eliminating the need for complex, scalp-based electrodes long used in brain monitoring.
