-by Craig Idlebrook, Glu community and content manager/GluCraig
UPDATE 6/21/2018 – The FDA has approved Senseonic’s Eversense implantable CGM on June 21, 2018. The device, which is implantable for up to 90 days, will be the first implantable CGM on the market. To read the press release for the FDA approval, go to http://www.senseonics.com/investor-relations/news-releases/2018/06-21-2018-201353063.
Details about the device can be found in this article about an FDA advisory panel decision to back the approval of the implantable CGM below:
An FDA advisory panel voted 8 to 0 to recommend approval for Senseonic’s Eversense, an implantable continuous glucose monitor (CGM). If FDA regulators accept the unanimous recommendation of its advisory panel, the device would be the first implantable CGM to enter the U.S. market. An earlier version of the implantable CGM already is approved for use in the European Union.
At the late March meeting, advisory members evaluated data from three rounds of successful clinical trials, as well as the design of both the CGM and the tool used to implant the device. The clinical data satisfied the advisory members as to the device’s safety and effectiveness.
The Eversense CGM is implanted just under the skin during a short procedure in a doctor’s office, and can be used for up to 90 days at a time. Users wear a transmitter on top of the skin over where the sensor is implanted; the transmitter is attached to the skin through an adhesive patch. Users would still need to calibrate the CGM with fingersticks.
If the CGM is approved by the FDA, Senseonic officials plan to conduct post-approval research to monitor for safety and effectiveness of the device. The company proposes a two-year study of 175 adults with diabetes. Senseonic is already conducting post-approval research of the CGM in Europe, where some 1700 people with diabetes already are wearing a similar version of the device.
If the Eversense CGM is approved, it will join a CGM market that has become much more competitive in recent months, what with the recent releases of the Dexcom G6, the Abbott, the Medtronic Guardian Connect, and the Freestyle Libre Flash.
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To read FDA background material prepared for the advisory panel, click here: goo.gl/5Dy2V7
To read the announcement about the 8 to 0 vote, click here:https://www.businesswire.com/news/home/20180329006248/en/