Having streamlined its regulations for digital devices about a year ago, the FDA has now approved a continuous glucose monitoring sensor that can be implanted into the patient’s body. This continuous glucose monitoring system called Eversense transmits data from a sensor implanted into the patient to a paired mobile app which lets users see their glucose levels on their mobile device. This is the first sensor of its kind that has been approved by the FDA.
The approval for the Eversense system came following a 125-person study which reported that less than one percent of the study’s participants reported serious adverse reactions to the implant.
One big caveat is that the sensor may only be implanted and retrieved by qualified medical professionals. Once it’s implanted, the sensor can stay in the body for up to 90 days. That’s far longer than many external sensors that often have to be removed in less than two weeks.
The sensor is placed inside the patient’s skin and has a fluorescent chemical coating which produces light when it’s exposed to glucose. It can then read whether the levels are high or low and then send measurements to the paired app in five minute intervals.
Another study will be conducted post-approval but an FDA advisory committee has unanimously recommended that the system’s benefits far outweigh the risks.
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