Phone Based FDA Cleared Glucometer, Now Available in U.S.

iHealth

iHealth Lab, part of China-based Andon Health, has received FDA clearance and is launching its iHealth Align blood glucose monitor in the U.S. This is the smallest FDA cleared glucometer, but it requires an Android or iOS device to take readings. The device is plugged into the 3.5 mm headphone jack of your phone/tablet and from there it’s operated pretty much like any other glucometer, with all the interaction done through the phone/tablet’s touchscreen. The device will  be sold for $17, which comes with a lance and four cases of different colors, while the test strips are $12.50 for a set of 50.

iHealth’s Gluco-Smart app is used to store glucose readings and insulin injections, and to retrieve historic data to check on one’s ability to maintain healthy blood glucose levels. The app also uploads all the data to the “cloud” where it can be accessed by the person’s doctor, caretaker, or anyone else that has an access. No word on if this app or testing will work with Apple’s HealthKit, or if Apple is going to challenge the name iHealth.

iHealth-AligniHealth also announced the iHealth Simple Savings program to eliminate complexities associated with insurance paperwork by significantly lowering the price of their proprietary test strips. The new price is about one-quarter of the list price of most name brand test strips, placing it at or below the typical insurance co-pay contribution. Users can now purchase iHealth strips and avoid hassles associated with reimbursement for insurance coverage.

The Simple Savings program will also incorporate an option in the near future to automate test strip replenishment through the iHealth Gluco-Smart mobile app, which intelligently tracks individual test strip usage, allowing for accurate and timely refills.