Continuous Glucose Monitors: FDA Grants Pediatric Indication to Medtronic Device, Approves Senseonics System

Regulatory NewsRegulatory News | 22 June 2018 |  By 

The US Food and Drug Administration (FDA) announced late Thursday expanded and new approvals of two diabetes management devices—Medtronic’s MiniMed 670G hybrid closed looped system and Senseonics’ Eversense continuous glucose monitoring (CGM) system.
Both of these CGM systems are designed to measure glucose levels in patients’ body every five minutes using sensors surgically implanted under the skin.
Medtronic’s expanded approval allows for the automated insulin and monitoring system to be used in pediatric patients with type 1 diabetes of at least 7 years of age. The company initially received FDA approval for the system last September for type 1 diabetes patients who are at least 14 years old.
The MiniMed 670G system’s sensor is designed to automatically adjust insulin delivery doses with the included catheter. The system also features an insulin pump and an infusion patch.
According to FDA, Senseonics’ CGM system is the first-ever to feature a sensor that is “fully implantable” and can measure patients’ glucose levels for up to 90 days. Its technology provides for the collected data to alert users of potential health complications via a mobile app.
“This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms,” FDA Commissioner Scott Gottlieb said.
Gottlieb also highlighted the efforts already underway at the agency’s Center for Devices and Radiological Health (CDRH) to use industry and the general public’s input to co-create a new regulatory approach on digital health software tools, such as mobile medical apps, through its pre-certification pilot program. “We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities,” he said.
Earlier this week, CDRH released version 0.2 of the pre-cert working model, pointing to the areas in need of further refinement and adding details on different components of the program.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy