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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Zeto New Wave EEG System for Outpatient and Home Recordings

The headset-style system is limited to recordings of up to 2.5 hours and is not intended for inpatient or hospital use.

By News DeskApril 2, 20262 min read
A seated woman wearing an EEG headset beside a laptop showing brainwave traces
A woman demonstrates a Zeto EEG headset in a clinic chair, with the recording shown on a laptop and a mounted display. Photo: Zeto · Company press image published with the release
FDA cleared510(k) · K260455FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared Zeto New Wave under a Special 510(k), K260455, on March 13, 2026; Zeto announced it on April 2.
  • The cleared indication covers outpatient facilities and home use for adults and children, excluding newborns, for recordings of up to 2.5 hours.
  • The predicate is Zeto's own Flexset system, now sold as Zeto ONE for hospital and transport settings.

The US Food and Drug Administration has cleared Zeto New Wave, an electroencephalogram (EEG) system for recording brain activity in outpatient clinics and at home, Zeto announced on April 2.

Zeto said patients across the US often wait weeks for an EEG appointment and that clinics face shortages of specialized EEG technologists. The company said New Wave is meant to address both problems with a simpler outpatient routine EEG setup.

What the FDA cleared

The FDA's 510(k) database lists K260455 for the New Wave System. The agency received the submission on February 11, 2026, and cleared it on March 13, 2026. It was reviewed as a Special 510(k); the summary says New Wave has the same intended use and technological characteristics as its predicate apart from minor modifications.

According to the 510(k) summary, the system is intended "for prescription use in an outpatient healthcare facility, or home use to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns." It can also record ECG, eye-movement and muscle signals, orientation sensor data, photic sensor data, external triggers and video. The summary lists contraindications: newborns, inpatient or hospital use, recordings longer than 2.5 hours, and use as a replacement for comprehensive neurological evaluation or diagnosis.

The predicate is Zeto's Flexset System, cleared as K233403. The summary says the two share the same intended use and that New Wave's indications are narrower: Flexset is cleared for a broader range of settings, including healthcare facilities and transport, and for longer monitoring. The summary describes New Wave as using 19 signal electrodes and one active ground electrode placed according to the 10-20 system; the company describes "21 soft-tip, no mess electrodes."

Zeto's product line

New Wave is Zeto's third FDA-cleared device, after the WR19 and the ONE, the company said. Zeto's own caution statement identifies ONE as the product cleared under K233403, formerly called Flexset.

"We listened to neurologists' needs and designed a system that helps clinics expand access to EEG, address staffing challenges, and improve patient experience," Chief Executive Florian Strelzyk said, as quoted by Medical Economics. Strelzyk said New Wave was built on lessons from the company's first-generation WR19 device. In the company's release, he said the ONE was released in 2024 for intensive care units, emergency departments and patient transport, and that both systems run on the Zeto Cloud platform for remote access.

Zeto said it also provides AI-powered seizure detection, seizure burden analysis and other quantitative analytics. The company did not disclose pricing for New Wave.

Sources

  1. Zeto Announces FDA 510(k) Clearance of Zeto New Wave, Advancing Efficiency in Outpatient EEG, Zeto, April 2, 2026
  2. Zeto receives FDA Clearance for outpatient EEG system, Medical Economics, April 2, 2026
  3. 510(k) K260455: New Wave System (database record), US Food and Drug Administration, March 13, 2026
  4. K260455 clearance letter and 510(k) summary, US Food and Drug Administration, March 13, 2026