Companion Medical announced that it won FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation in diabetes management.
The new bolus calculator is designed to account for the user’s current glucose level and active insulin to remove the guesswork from insulin dosing. Companion Medical touts the system as the first of its kind to win clearance for those with Type 1 or Type 2 insulin-dependent diabetes who administer a fixed amount of insulin for meals or deliver a dose based on the approximate size of their planned meal.
San Dieg–-based Companion Medical’s InPen includes a smartpen and a Bluetooth-connected app. Altogether, is designed to help calculate insulin doses, track active insulin and send reports to caregivers. The platform is available in the U.S. by prescription only, while the app is available for download through the Apple App Store and Google Play, according to a news release.
Janice MacLeod, who leads Companion Medical’s clinical advocacy efforts, said in the news release that the InPen platform offers a new option to patients who aren’t able to or would not like to count carbs for every meal, while it helps avoid stacking insulin and it minimizes the risk of low glucose.
“Our goal since launching in 2017 has been to make insulin therapy simpler for all people with diabetes – not just the most engaged or advanced,” Companion Medical founder & CEO Sean Saint said in the release. “We do this by letting the InPen system do most of the heavy lifting and ease the burden. Similar to the first InPen dose calculator, which has been a game-changer for those of us who count carbs, this new FDA clearance for users on fixed-dose or meal estimation therapy finally offers a simple, yet advanced solution to those people living with insulin-dependent diabetes who are not expert carb counters.”