US-based digital health company STAT Health has introduced a 24/7 in-ear wearable general wellness product that measures blood flow to the head to allow a better understanding of conditions in the body that occur upon standing.

As the world’s smallest wearable, the technology will address symptoms such as dizziness, brain fog, headaches, fainting, and fatigue, commonly associated with illnesses like long Covid, postural orthostatic tachycardia syndrome, myalgic encephalomyelitis/chronic fatigue syndrome where blood flow to the head is reduced upon standing. These conditions affect more than 13 million Americans.

The wearable device has been clinically tested at Johns Hopkins and peer-reviewed in the March 2023 issue of the Journal of the American College of Cardiology. It can predict a person fainting minutes before it happens and can be worn with more than 90% of devices that go in or around the ear. It can also be left in while sleeping and showering, meaning less likelihood of removing the device and forgetting to replace it.

Entrepreneur and co-founder of STAT health, Daniel Lee, has been developing in-ear devices since leaving college, having worked with Bose on his Sleepbud product. He told Medical Device Network that the wearable will help the target population navigate their condition better. “For this population, if they’re not standing when they can, they will become deconditioned. This product encourages standing and being upright where possible, as part of rehab.” Still, Lee warned against pushing rehab if the body is not getting enough blood flow to the brain as that may cause flare-ups.

Previous studies have used ultrasound to show that cerebral blood flow is the key biomarker that objectively measures the presence and severity of many invisible illnesses. The STAT technology uses an optical sensor instead of ultrasound and taps into a shallow ear artery to measure a proxy to ultrasound-derived cerebral blood flow, being close to the brain and major arteries. This positioning also frees it from complications caused by arm movement, a problem that can prevent current wearables from monitoring heart metrics during many daily tasks.

Despite its small scale, the device incorporates advanced optical sensors, an accelerometer, a pressure sensor, temperature sensors, artificial intelligence (AI)-edge computing, 3+ day battery life, and a micro solar panel. The product connects to an app, showing the wearer how heart rate, blood pressure trends, and blood flow to the head change upon standing.

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As a general wellness product, this device is not FDA-approved. However, STAT Health is running clinical validations and hopes to get FDA approval for similar products that it will design in the future. The company is backed by $5.1 million in seed funding from J2 Ventures, BonAngels Venture Partners, and a diverse group of prominent angel investors. It has also received grant funding from the US Air Force.