First Home OSA Detecting Device Gets Approved by FDA
written by/ December 22, 2021
Detecting a sleep breathing condition can be tricky, especially if you sleep alone. Luckily, very soon, you’ll be able to home-test for the most common among such conditions—Obstructive Sleep Apnea (OSA). All thanks to an FDA-approved device called AcuPebble SA100.
Around 26% of Americans aged 30–70 suffer from sleep apnea, according to data from the American Academy of Sleep Medicine (AASM).
What happens in OSA sufferers during sleep is that they experience multiple short-episode breathing pauses, which interrupts their sleep cycle without them even realizing it. Symptoms like fatigue and loss of concentration are so frequent that they tend to get overlooked.
Until recently, OSA diagnosis included visits to a specialist. Plus, an available at-home diagnosis included a portable breathing monitor, finger clip, nasal cannula, and multiple chest sensors. Fortunately, all of these can now be replaced by a tiny monitor—AcuPebble SA100.
So, how does it work?
The device is meant to be worn on the base of the neck. From there, it records the sounds generated by your respiratory system and monitors cardiac functions.
The data is continuously transferred wirelessly and stored on a cloud platform. Algorithms analyze it and give a diagnosis that health professionals can access through a specialized app. Therefore, you’ll get an accurate diagnosis quite fast.
The AcuPebble SA100 reaches diagnoses primarily by monitoring the apnea-hypopnea index (AHI) and the oxygen desaturation index (ODI). What’s more, this small device also provides information on the severity of one’s condition.
We’ll be able to take full advantage of this wearable because it just received a Class II medical device clearance—FDA 510(k). The green light comes after several successful clinical trials conducted in London—part of a ten years-long research led by Acurable.
Once AcuPebble SA100 hits the shelves, it will enable OSA patients to start treatment sooner, and severe cases will be prescribed CPAP machine therapy. This way, they’ll prevent the negative effects of this health condition, like obesity, CVDs, high blood-pressure, or diabetes.