iHealth gets FDA clearance for medical-grade pulse ox

By: Jonah Comstock | Oct 7, 2013        

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iHealth's existing consumer pulse oximeter.

iHealth’s existing consumer pulse oximeter.

iHealth Labs, a subsidiary of China-based medical device company Andon Health, has received FDA clearance for a wireless fingertip pulse oximeter, which will be a distinct offering from the consumer pulse oximeter the company announced at CES last year and currently sells on its website.

“Basically we’re coming out with an FDA-[cleared] version,” iHealth Labs president Adam Lin told MobiHealthNews. “Our first one we’re selling at the Apple store, at Best Buy, marketed as more of a fitness device.”

Pulse oximetry can be used by climbers, pilots, and even runners to check their level of blood oxygenation. Companies that market their devices for sports and fitness exclusively, such as Masimohave historically opted out of FDA 510(k) clearance. iHealth’s current offering is sold for $69.95 on the company’s website. It measures the user’s blood oxygen saturation and pulse rate and displays readings both on the device’s LED screen and on a connected iOS app, the iHealth SpO2 app. It connects to the app via Bluetooth.

Lin said the new device will be marketed for medical use cases, such as home health monitoring. It will have “one or two new features” but with a very similar look, he said. The company plans to launch the device some time in 2014. Though the device will cater to a more medical use case, particularly heart health, it will be available over the counter, not just by prescription.

iHealth Labs launched an activity tracker in May, the latest product in a suite that includes several connected blood pressure monitors and smart weight scales. The company has also announced a connected glucometer, though it is not yet available for purchase, at least not via iHealth’s website.

Nonin also scored FDA 510(k) clearance for a pulse oximeter, the Nonin 3230 Bluetooth Smart-enabled device announced at ATA in May. Nonin makes the Onyx mobile pulse oximeter, which is used in a number of home health services including Robert Bosch Healthcare, GE Intel Care Innovations, and Qualcomm Life. Bluetooth Smart will allow the device to pair more quickly and easily with connected hubs and apps, have a longer battery life, and be offered at a lower cost, Nonin spokespeople told MobiHealthNews in May.