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FDA Expands Indication for Smart Insulin Pen

The FDA recently approved the smart insulin pen, InPen, for use in pediatric patients with type 1 diabetes.The InPen was previously approved only for adults and children older than 12 years.

The InPen is an at-home reusable insulin self-injector that allows patients to dial the desired dose from 0.5 to 30 units.

The InPen also uses Bluetooth to sync with a mobile app that assist patients with dose calculation, injection reminders, and monitor active insulin.

"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," he continued. "Now that InPen is approved for all ages, the intelligence in the InPen app… can help caregivers feel more confident as they're learning how to manage their children's diabetes.”

According to the press release, the smart insulin pen also gives health care providers access to patient insulin use data in order to optimize diabetes management plans.

According to an FDA filing, the InPen is compatible with Novolog insulin aspart injection U-100 3.0 mL cartridges.

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