Summary: Snap Diagnostics has received FDA 510(k) clearance for its new wearable home sleep testing device, the Sleep Apnea Monitor (SAM) Model 9-10000. This next-generation device is designed to be smaller, easier to set up, and offers enhanced diagnostics compared to its predecessor. It includes features such as type III testing, a proprietary sound/snoring channel, wireless sensors, and extended battery life.
Key Takeaways:
- Snap Diagnostics’ Sleep Apnea Monitor (SAM) Model 9-10000 has received 510(k) clearance from the US FDA, enabling its use as a home sleep testing device.
- The SAM Model 9-10000 incorporates a wearable design with wireless sensors, extended battery life, and a proprietary sound/snoring channel for improved patient convenience and diagnostic accuracy.
- The device provides type III testing with direct airflow, respiratory effort, oximetry, and heart rate monitoring, and offers manually scored raw data in a standard American Academy of Sleep Medicine format.
Snap Diagnostics has received 510(k) clearance from the US Food and Drug Administration for its wearable home sleep testing device, Sleep Apnea Monitor (SAM) Model 9-10000.
The next-generation SAM Model 9-10000 builds on current Snap technology, with a smaller size, simplified setup for patients, and enhanced diagnostics.
“The SAM device combines the form factor of a wearable with Snap’s full range of channels, including true airflow and a respiratory effort belt. This sets our device apart in terms of convenience, quality, and accuracy,” says Gil Raviv, president of Snap Diagnostics, in a release.
Features of the SAM Model 9-10000 include:
- Type III testing with direct airflow, respiratory effort, oximetry, and heart rate
- Proprietary Snap sound/snoring channel
- Wireless sensors
- Extended battery life (three-plus nights)
- Manually scored raw data in a standard American Academy of Sleep Medicine format
Photo caption: Sleep Apnea Monitor (SAM) Model 9-10000
Photo credit: Snap Diagnostics
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