Companion Medical InPen Receives FDA Clearance for Expanded Pediatric Use

Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, has announced that they received FDA expanded clearance for all ages to use the InPen System.

"We are excited that we can help younger children and even more parents navigate the challenges associated with Type 1 diabetes. Now anyone can safely use InPen to help make decisions around insulin dosing, no matter what their age," said Sean Saint, CEO and co-founder of Companion Medical. "Receiving a diagnosis that your child has Type 1 diabetes is a very scary and confusing time. Now that InPen is approved for all ages, the intelligence in the InPen app – including active insulin, a dose calculator to help them calculate the right amount of insulin and auto-tracking of insulin doses – can help caregivers feel more confident as they're learning how to manage their children's diabetes. It also enables healthcare providers access to additional insights so they can make improvements and adjustments to the child's diabetes management plan."

Companion Medical's InPen is the only FDA-cleared, smart insulin pen system that combines a reusable, Bluetooth® insulin pen and an intuitive mobile app that helps users take the right insulin dose, at the right time. With a custom dose calculator, dosing reminders and the ability to see active insulin, InPen takes the guesswork out of managing diabetes.

"The parents of our newly diagnosed patients with Type 1 diabetes are often overwhelmed with the many responsibilities involved in attempting to successfully treat and manage diabetes," said Dr. Stelios Mantis, MD, MPH and Assistant Professor, Department of Pediatrics at Rush Medical College. "InPen alleviates some of the challenges of managing diabetes in young children including assisting with dosing calculations for meals and correction doses for unexpected hyperglycemia. Just as important, InPen is able to track all doses of insulin, and thus relieving families of the burden of trying to recall when and how much insulin was dosed over any given period of time. This gives parents and kids time for some of the important aspects of childhood; learning new concepts in their education, partaking in activities with their peers, and enjoying their childhood."