FDA OKs Novo Nordisk’s Fiasp Insulin for Companion Medical’s InPen

Companion Medical, manufacturer of InPen, the first FDA-cleared smart insulin pen and mobile app-based diabetes management system, announced clearance by the FDA for the use of Novo Nordisk’s Fiasp rapid-acting insulin. The clearance adds to its existing solutions for managing insulin-dependent diabetes, which to date has supported Humalog and Novolog.
 
Fiasp is indicated for dosing at mealtime, or within 20 minutes after starting a meal, and is recommended for patients who need dose timing flexibility or who tend to dose late. “Companion Medical’s goals are to create affordable, easy-to-use solutions that allow people with diabetes to focus more on their lives and less on their condition,” said Sean Saint, CEO of Companion Medical. “Our customers tell us that the InPen system has changed their lives and indicating another rapid-acting insulin allows us to expand to more people living with diabetes, including those who want more dose timing flexibility.”
 
People living with diabetes rely on the InPen system—which includes a smart insulin pen connected to an integrated diabetes management app—to help them calculate insulin doses, receive missed dose reminders, track active insulin, and send reports from their phones directly to their caregivers. The “Insights by InPen” report aggregates glucose, insulin, and meal data into detailed reports with daily views which enables providers to monitor glucose control and adherence patterns, identify the cause and effect of diabetes decisions, and help make more informed targeted improvements to therapy.
 
InPen is available in the U.S. by prescription only. The app is available for download on the Apple App Store and Google Play.