Medtronic wins FDA’s breakthrough status for closed-loop insulin system

Tuesday, February 19, 2019

Source: MassDevice

Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system.

The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion.

Medtronic’s November acquisition of nutrition data science company Nutrino Health will play a role in the development of its closed-loop insulin pump system, according to the medtech titan.

“We are very excited to receive the Breakthrough Device designation from the FDA as it will help us deliver this broadly anticipated innovation to patients much sooner than expected,” Alejandro Galindo, president of the advanced insulin management division within Medtronic’s diabetes business, said in prepared remarks.

“We believe the personalized closed loop system will be transformational for diabetes management, and the personalized nature of the algorithm clears the path to a true closed loop system. We have a long history of partnership with the FDA and look forward to another successful collaboration with the agency to bring this important innovation to patients,” Galindo added.

“It is incredibly rewarding as an endocrinologist to see this novel closed loop innovation in development as it holds significant promise for simplifying diabetes management and taking on much more of the work on behalf of the patient,” Dr. Kevin Kaiserman, a pediatric endocrinologist at SoCal Diabetes, said.

Medtronic was the first to win FDA approval for a hybrid closed-loop insulin delivery system. The FDA approved Medtronic’s MiniMed 670G system in September of 2016.

A hybrid closed-loop system, as the name suggests, is not fully automated – it still requires users to manually enter food data and correct insulin boluses.

In June last year, the FDA expanded its approval for Medtronic’s MiniMed 670G system to include people ages 7 to 13 with Type I diabetes.

Medtronic is also working with IBM Watson on a feature for its Sugar.IQ personal diabetes assistant app that can predict the likelihood of a low glucose event within a four-hour window.

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