Zeto New Wave Cleared
The FDA cleared Zeto’s New Wave system for outpatient routine EEG, a 21‑electrode, cloud‑connected device the company says will expand clinic access. (sleepreviewmag.com). Staffing shortages across healthcare are being cited as the context for selling connected diagnostics as a way to standardise acquisition and extend specialist oversight. (dailykos.com)
An electroencephalogram, or EEG, records the brain’s electrical activity through electrodes placed on the scalp. On April 2, Zeto said the Food and Drug Administration cleared its New Wave system for routine outpatient use. (medlineplus.gov) (prnewswire.com) The new device uses 21 soft-tip electrodes arranged under the standard 10-20 placement system, the layout widely used for clinical scalp EEG. Zeto said the system is built for outpatient clinics and home-based providers rather than hospital intensive care units. (acns.org) (sleepreviewmag.com) Zeto said New Wave records up to 2.5 hours and can capture synchronized video and audio, plus optional signals such as electrocardiography, electrooculography and electromyography. The company said it will offer adult and pediatric sizes. (medicaleconomics.com) (sleepreviewmag.com) Food and Drug Administration 510(k) clearance does not mean a device is being approved as a brand-new product category. It means the agency found it substantially equivalent to a legally marketed device through the premarket notification process. (fda.gov) Routine EEG still depends on getting enough electrodes onto enough parts of the scalp at the same time. The American Clinical Neurophysiology Society says using too few channels increases the chance of interpretation errors, which is why full-head systems remain the clinical baseline. (acns.org) Zeto is pitching New Wave around a staffing problem as much as a hardware upgrade. Company statements and trade coverage say clinics are dealing with long waits for EEG appointments and shortages of specialized EEG technologists. (massdevice.com) (fiercebiotech.com) That sales pitch fits a broader workforce squeeze across outpatient care. Federal workforce projections and hospital industry reports say shortages are expected to persist across multiple health occupations, with rural and underserved areas under the most pressure. (bhw.hrsa.gov) (aha.org) Zeto said both New Wave and its other cleared EEG systems run on the company’s cloud platform, which lets specialists review studies remotely. The company said the new clearance is its third Food and Drug Administration-cleared device, alongside Zeto WR19 and Zeto ONE. (zeto-inc.com) (fiercebiotech.com) The immediate change is practical: a routine brain-wave test that usually starts with a technologist at a bedside is being repackaged for clinics and some home settings. The next test for Zeto is whether easier setup and remote review actually cut the wait for patients who need an EEG. (medlineplus.gov) (sleepreviewmag.com)
