FDA clears smart insulin pen for children with diabetes
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The FDA granted clearance for a smart insulin pen to be used by children with diabetes aged at least 7 years, according to an industry press release.
As Healio previously reported, the InPen system (Companion Medical) has been commercially available for iOS users since December 2017 and is the only FDA-cleared smart insulin pen paired with an integrated diabetes management app.
“We are excited that we can help younger children and even more parents navigate the challenges associated with type 1 diabetes,” Sean Saint, CEO and co-founder of Companion Medical, said in the release. “Now anyone can safely use InPen to help make decisions around insulin dosing, no matter what their age.”
InPen combines a reusable, Bluetooth-enabled insulin pen and mobile app that helps users take the right insulin dose, at the right time. The system includes a custom dose calculator, dosing reminders and the ability to see active insulin.
“Receiving a diagnosis that your child has type 1 diabetes is a very scary and confusing time,” Saint said in the release. “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 health care providers access to additional insights so they can make improvements and adjustments to the child’s diabetes management plan.”
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