Smart Insulin Delivery System FDA Approved

Companion Medical announced 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.

Product information can be found from Companion Medical website.

Bigfoot Biomedical Enrolls Clinical Trial of Automated Insulin Delivery System

“Life with T1D using today’s tools is unreasonable,” according to Jeffrey Brewer, founder & chief executive officer of Bigfoot Biomedical. “Therapies are too expensive, too complex, and require intense focus and attention with little support. Also, healthcare providers are overwhelmed, with too many hurdles blocking them from helping their patients. The smartloop™ automated insulin delivery system has the potential to change people’s lives. It is designed to deliver better health with greater ease of use, making life simpler for both the patient and the clinicians who treat them, ultimately lowering cost of treatment.”

Motivated by a desire to improve the lives of their children, Jeffrey Brewer, former CEO of JDRF International, and Bryan Mazlish, the mysterious “Bigfoot” in Dan Hurley’s piece for Wired Magazine, founded Bigfoot Biomedical in November 2014. Moving with unprecedented speed in medical device development, over the past 20 months they’ve assembled a team of 40 people and are driving toward commercialization of a cutting edge approach to improving the lives of people with T1D.



Bigfoot recently received approval by the FDA of its Investigational Device Exemption (IDE) submission for a first clinical study of the smartloop™ automated insulin delivery system. The trial is slated to take place at three sites, each of which is a global leader in closed-loop insulin delivery research. Bigfoot is collaborating with Stanford University School of Medicine in coordination with Lucile Packard Children's Hospital Stanford and Stanford Children's Health in Palo Alto, CA, the William Sansum Diabetes Center in Santa Barbara, CA, and the Barbara Davis Center for Diabetes at the University of Colorado School of Medicine in Aurora, CO.

A press release can be found from Bigfoot Biomedical website.