- Medtronic will submit its Bluetooth-enabled Guardian Connect mobile CGM to the FDA in early March, with launch expected by April 2017. The product will launch in Europe this summer. Guardian Connect sends CGM data directly from the on-body transmitter to an iPhone app via Bluetooth â no pump or receiver required. This is similar to Dexcomâs G5 and Abbottâs LibreLink (Sweden-only), and opens up Medtronic CGM to those not on pumps. Guardian Connect will use the more accurate Enlite 3 sensor. The current MiniMed Connect app does receive Medtronic CGM data, though it requires a key-fob sized ârelayâ device to receive data from the pump.
- An FDA submission for the MiniMed 670G/Enlite 3 hybrid closed loop system is targeted before the end of June, meaning a launch by April 2017 is still possible. Enrollment in theÂ US pivotal studyÂ will complete in the ânext few weeks,â which is slightly different fromÂ Dr. Fran Kaufmanâs expectation at ATTDÂ that the trial would end in late February. More than 75% of trial participants continue to use the system as part of the FDAâs continued access program â thatâs a strong vote of confidence that patients really like the device.
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