OxiWear receives FDA clearance for continuous blood oxygen ear clip that works even during motion

OxiWear has received FDA clearance for its continuous blood oxygen monitor that works even during motion. Other monitors can only measure accurately when users are at rest or are not FDA-cleared as a medical device for accuracy and safety. The ear-wearable alerts the user to low oxygen levels and can call emergency services.

Smartwatches such as the Apple Watch have been found to be inaccurate. In a review of five publications, blood oxygen saturation (SpO2) measurements of the Watch varied +/- 2.7 to 5.9%, with outliers as much as 15%. For patients suffering from heart and lung diseases, this degree of oxygen reduction (hypoxia) can result in blackouts and death because their bodies already receive diminished amounts of oxygen. This was the motivating reason for founder Shavini Fernando, who suffers from severe pulmonary hypertension, to create OxiWear.

The ear-wearable is the only FDA-cleared device that can measure blood oxygen saturation while the user is sitting or in motion. Other monitors can only measure accurately when the patient is at rest. The OxiWear monitor can continuously monitor SpO2 levels to detect pending emergencies and alert the wearer of dropping levels by vibrating. As necessary, the device will automatically notify designated emergency contacts by text in addition to contacting 911 emergency services.

The mobile app for Android and Apple smartphones provides live, continuous health tracking of blood oxygen saturation (SpO2), heart rate (bpm), altitude, humidity, barometric pressure, and air quality. This allows users to better understand the environmental triggers for health episodes. The alert threshold for oxygen can be set between 92% to 97%. Reports with five hours of oxygen data can be downloaded or emailed for premium subscribers. OxiWear does not need to be connected to the mobile app to operate and detect low blood oxygen levels.

The OxiWear bundle package has a $500.00 MSRP (available here on Amazon). The package includes the ear wearable, a charger case, three adjustment pads, and a charger cable. An optional charging case with a $175.00 MSRP provides two extra charges for a total runtime of 24-hours for the OxiWear. A set of interchangeable faceplates with a $49.99 MSRP allows users to customize the color of their OxiWear. The water-resistant monitor can be disinfected with alcohol wipes.

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