The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the InPen system, a wireless-enabled insulin pen and proprietary mobile application from Companion Medical.
The InPen includes technology to:
- Calculate and recommend optimal dosing
- Track history and timing of doses
- Monitor insulin temperature
- Display last dose and insulin-on-board
- Track and report to the health care provider
Companion Medical’s InPen is cleared in the U.S. for use with Lilly Humalog or Novo Nordisk Novolog rapid acting insulin. The InPen app is also cleared for Apple iOS, with an Android version planned for late 2016. The company has also filed for CE Mark.
“The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally,” said Sean Saint, Chief Executive Officer of Companion Medical.
“Diabetes is a complex and burdensome condition requiring accurate insulin doses to stabilize blood sugar levels and prevent long-term complications,” said Dr. Timothy Bailey. “Smart pens offer an improved dosing option for people living with diabetes, the majority of whom do not use insulin pumps. The InPen adds a clinician-configured bolus calculator to the ability to give multiple doses of insulin each day safely and discreetly. The insulin data can be shared with clinicians, allowing for optimized treatment planning.”
Diabetes is a chronic, life-threatening disease caused by the body’s failure to produce sufficient insulin or to utilize it effectively to control blood glucose levels. The majority of people worldwide that require insulin utilize syringes or insulin pens.