Good News For Senseonics, Medtronic Diabetes Devices
US FDA recently approved the first 90-day CGM system and expanded the labeling for a closed-loop system to treat diabetes.
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Results Recap: Support For Medtronic's 'Suspend Before Low' Insulin Pump Feature; Neuroelectrics' Starstim Treats Epilepsy Seizures
Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 22 through Feb. 28, includes published results from trials of Medtronic’s closed-loop artificial pancreas, Neuroelectrics’ nerve stimulation device to treat seizures, and Myriad’s companion diagnostic for pancreatic cancer.
It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.
US FDA approved the Eversense CGM System for continually measuring glucose levels in adults with diabetes for up to 90 days, and the company is working on clinical evidence to support a 365-day indication, as well as working with Roche and Beta Bionics to include its sensor technology in fully integrated artificial pancreas systems