The FDA-cleared device is designed to be a compatible platform to support future accessories.
Key takeaways:
- WatchPAT 400 is a new FDA-cleared home sleep test that utilizes a smartphone app for immediate access to study results.
- The reusable device captures seven channels, detects central sleep apnea and atrial fibrillation, and boasts an 89% correlation to polysomnography in AHI, according to ZOLL Itamar.
- It is commercially available in the US and the EU.
At SLEEP 2026, ZOLL Itamar revealed the reusable WatchPAT 400, a new US Food and Drug Administration (FDA)-cleared home sleep test designed to offer a streamlined, app-connected experience for sleep diagnostics.
The device, which received FDA 510(k) clearance in September, builds on the efficiency of the reusable WatchPAT 300 while incorporating the simplicity and control of the disposable WatchPAT ONE, according to ZOLL Itamar. It is designed to be a compatible platform to support future accessories.
According to the company, the device utilizes a smartphone app that allows immediate access to sleep results after study completion, helping to improve both operational efficiency and patient compliance.
Key features of the WatchPAT 400 include:
- Provides immediate access to study results with a smartphone application after study completion.
- Features an easy setup process with the WatchPAT app and three points of contact.
- Captures seven channels with four respiratory indices.
- Demonstrates an 89% correlation to polysomnography in apnea-hypopnea index (AHI), according to the company.
- Utilizes total sleep time for AHI calculation, similar to other WatchPAT devices.
- Detects apnea/hypopnea events and differentiates central sleep apnea events, with the added value of detecting atrial fibrillation events and premature beats.
- Includes hypoxic burden in the latest sleep reports.
- Utilizes SleePATh functionality for increased patient communication and compliance.
The WatchPAT 400 currently commercially available in the United States and European Union.
