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FDA approves Medtronic’s Enlite Sensor for iPro2 Professional CGM system

Medtronic has received approval from the US Food and Drug Administration (FDA) for its Enlitesensor for use with iPro2 Professional continuous glucose monitoring (CGM) system.

The Enlite is a disposable glucose sensor that can be worn up to six days. It is claimed to be 69% smaller than the previous Medtronic sensor.

The iPro2 system also features a small data recorder, which automatically records glucose information. It will record glucose levels of the patient round the clock for up to six days.

Patients can wear the small, lightweight, discreet and watertight device without disturbing the normal daily activities. Later, it will be provided to clinician for evaluation.

The system enables physicians to know how the nutrition plan, medication regimen and daily activities affect glucose levels of people with diabetes.

According to the company, the CGM system captures up to 288 measurements per day to reveal hidden high glucose (hyperglycemia) and low glucose (hypoglycemia) fluctuations.

Medtronic non-intensive diabetes therapies general manager and vice president Laura Stoltenberg said: “We fundamentally believe that to improve outcomes for people with diabetes, physicians need advanced insights to optimize therapy and people with diabetes need to understand the context behind glucose fluctuations to drive behavior change.

"Our focus is to continuously enhance our professional CGM solutions and improve patient and physician experience by making the systems easier-to-use through advancements such as the Enlite sensor and our Pattern Snapshot report."