Companion Medical Receives FDA Clearance for Smart Insulin Delivery System

Thursday, July 28, 2016

Companion Medical, a leader in the development of advanced technology to improve diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the InPen® system, its wireless-enabled insulin pen and proprietary mobile application.  The InPen is the first and only FDA-cleared SmartPen™ that includes technology to:

    Calculate and recommend optimal dosing;
    Track history and timing of doses;
    Monitor insulin temperature;
    Display last dose and insulin-on-board; and
    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 cleared for Apple iOS with an Android version planned for late 2016.  The company has also filed for CE Mark.

"FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," said Sean Saint, Chief Executive Officer.  "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.  We are excited to be the first to introduce this entirely new class of insulin delivery."

"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.  People with diabetes are challenged to overcome the difficulties associated with delivering insulin multiple times per day.  Failure to adhere to an accurate dosing regimen can lead to long term health consequences including nerve damage, blindness, heart disease, and kidney disease.


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