Health Tech, Devices & Diagnostics

Abbott gets FDA clearance for CGM app

Abbott received FDA clearance for an app to pair with its Freestyle Libre 2 glucose monitor. The app lets people get readings directly on their phone without using a reader.

A woman scans a continuous glucose monitor with her smartphone

Abbott got FDA clearance for an app that lets people get their CGM readings on their phone. Photo credit: Abbott

Abbott Labs received clearance from the Food and Drug Administration for an app that pairs with its continuous glucose monitor (CGM).

The iPhone app would let people get glucose readings directly on their phone without using a reader. Users can scan a sensor built into the Freestyle Libre 2 to get their current glucose reading and trends. They can also share glucose readings and real-time alarms with caregivers. The app is cleared to be used by both adults and children, ages 4 and up.

Abbott received clearance for the Freestyle Libre 2 last year. The newest CGM was designed to be paired with other devices, such as its app, as well as smart insulin pens, such as the one developed by Bigfoot Biomedical. It transmits blood glucose data every minute using a Bluetooth signal, and also gives users the ability to set an alarm if blood glucose levels are too high or too low.

That said, Abbott isn’t the only company looking to make a connected CGM in this highly competitive market. San Diego-based Dexcom recently got FDA clearance to allow other digital health apps, such as Livongo and Garmin, to connect to its data through APIs. The company plans to release its newest CGM, the G7, later this year.