FDA clears wireless-enabled insulin pen for diabetes treatment
August 9, 2016
The US Food & Drug Administration (FDA) has granted 510(k) clearance for the Companion Medical InPen wireless-enabled insulin pen and proprietary mobile application.
The device calculates and recommends optimal dosing; tracks history and timing of doses; monitors insulin temperature; displays last dose and insulin-on-board; and tracks and reports to the health care provider.
The InPen is cleared in the USA for use with Lilly Humalog or Novo Nordisk Novolog rapid acting insulin. The app is cleared for Apple iOS with an Android version planned for late 2016. The company has also filed for a CE Mark.
"FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care," said Sean Saint, chief executive officer of California-based Companion Medical. "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 chronic, life-threatening disease caused by the body's failure to produce sufficient insulin or to use it effectively to control blood glucose levels. The majority of people worldwide that require insulin use 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.
"Diabetes is a complex and burdensome condition requiring accurate insulin doses to stabilise 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 optimised treatment planning."
Companion Medical is a privately held company based in San Diego. The company leverages cross-functional engineering expertise and clinical experience to develop products for diabetes management.
In the USA, approximately 26 million people have diabetes, a condition in which the body does not produce enough or properly use insulin, the hormone needed to convert sugar, starches and other food into energy needed for daily life.