Irish medical technology firm Medtronic has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Personalized Closed Loop (PCL) insulin pump system, which is currently under development.
Image: The FDA has granted breakthrough device designation for Medtronic’s PCL insulin pump system. Photo: courtesy of Medtronic.
Medtronic said that the PCL technology has been designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user.
The PCL system also offers exclusive insights and predictive diagnostics of the individual, enabling to simplify diabetes management for the patient.
Nutrino Health, which was recently acquired by Medtronic, will provide its expertise in nutrition data science to accelerate the development of the new breakthrough technology.
The FDA breakthrough device program was designed to help patients receive timely access to breakthrough technologies, enabling to provide effective treatment or diagnosis for different diseases and conditions.
As part of breakthrough device program, the FDA will offer Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, as well as commercialization decisions.
Medtronic diabetes group advanced insulin management division president Alejandro Galindo said: “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.
“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.”
Nutrino Health has developed food database and nutrition data insights platform, which collates data from millions of access points and food items across the globe.
The acquired business allows Medtronic to integrate Nutrino’s food analysis infrastructure, nutrition science expertise and artificial intelligence (AI)-driven personalized insights with its technology and future innovations for effective diabetes management.
Nutrino is also involved in the development of algorithms, which can predict glycemic responses to food.
With around 86,000 employees, Medtronic provides medical technology, services and solutions to the physicians, hospitals and patients in more than 150 countries.