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Medtronic wins FDA approval for diabetes management software

The artificial pancreas just got a brain.

Medtronic Inc. said Monday that the Food and Drug Administration has approved software that helps manage a patient’s diabetes therapy.

The company has been gradually assembling the parts for industry’s first artificial pancreas, an integrated system of technologies that can automatically adjust a patient’s insulin therapy based on blood sugar levels.

Earlier this year, Medtronic launched Revel, the first system to integrate sensors with the pump by alerting patients when their glucose levels fall out of a desired range. The patient can then more easily adjust the pumps accordingly. Eventually, a closed-loop system could act the same way a computer guides an airplane in autopilot mode.

Medtronic’s CareLink 3.0 software analyzes data from a patient’s insulin pump, continuous glucose monitoring (CGM) device, and blood glucose meter and identifies the exact times the patient experienced a low (hypoglycemic) or high (hyperglycemic) glucose pattern. CareLink then prioritizes the patterns so that doctors know which times of day are the biggest challenges for their patients.

“We know diabetes management is complex and that gathering adequate information to make informed treatment decisions can be a challenge for clinicians and patients,” Dr. Francine R. Kaufman, chief medical officer at Medtronic’s diabetes unit, said in a statement.

“Our goal with CareLink Pro 3.0 is to simplify this complexity by integrating patient data, helping providers identify patterns, and offering clinicians therapy considerations,” Kaufman said. “We believe decision support is a key advancement toward developing an artificial pancreas, which will rely upon automated decisions to make adjustments to patients’ therapy.”

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