Insulin Pen With Bolus Calculator App Cleared by FDA for Fixed Dosing, Meal Estimation

Companion Medical announced that it has received clearance from the Food and Drug Administration (FDA) for a new bolus calculator for fixed dosing and meal estimation to be used with the InPen system.

The InPen system includes an insulin injector pen (InPen) that pairs via Bluetooth with a smartphone app for the management of diabetes. The InPen app is able to calculate and recommend optimal insulin doses, monitor insulin temperature, remind users to take insulin, display last dose and insulin-on-board, and create reports for the healthcare providers using data transmitted from the pen. The new bolus calculator recommends a dose based on the previous insulin dose, current blood glucose level and the approximate size of the next meal.

InPen is compatible for use with Humalog® (insulin lispro; Eli Lilly), Novolog® (insulin aspart [rDNA origin]; Novo Nordisk) and Fiasp® (insulin aspart; Novo Nordisk) U-100 3.0mL insulin cartridges and single-use detachable and disposable needles (not included) in patients aged ≥12 years. The pen lasts for 1 year with no recharging needed. The accompanying mobile app can also synchronize glucose data from blood glucose meters and continuous glucose monitors via Apple Health. The app is available for download on the Apple App Store and Google Play.

Mike Mensinger, CTO and co-founder at Companion Medical commented, “With the new calculator modes, InPen provides an experience consistent with these patients’ current therapies, while adjusting recommendations automatically based on their current glucose level and factoring in active insulin to safely allow correction of high blood glucose between meals.”

For more information visit companionmedical.com.

This article originally appeared on MPR