Eversense Implantable Glucometer Gets FDA Approval as Alternative to Finger Tests

Senseonics, a company out of Germantown, Maryland, won FDA approval for its Eversense continuous glucose monitoring system. The system is intended to be used instead of traditional finger prick tests to make diabetes-related decisions. This is a giant step for the company, which has developed a technology that combines a tiny implant with a wearable transmitter to continuously measure glucose for 90 days at a time.

The Eversense implant is only 3.5 mm x 18 mm in size, and it is injected under the skin of the upper arm. The transmitter reads what the implant sensor is measuring, and sends regular updates to the patient’s paired smartphone, which keeps track of historical numbers. It can be removed at any time to recharge it or for the patient to take a shower, for example.

This transmitter can be programmed to independently vibrate when it notes that sugar levels go outside of healthy bounds, helping patients to quickly address their condition.

The system still requires the user to perform twice daily finger stick tests in order to calibrate it, which is certainly still an unpleasant nuisance, yet an improvement over the dozen or more tests that some people with diabetes have to put up with throughout the day.

“This FDA dosing indication helps reduce the burden that patients face when managing their diabetes,” said Francine R. Kaufman, MD, Endocrinologist and Chief Medical Officer at Senseonics, in a published statement. “Patients have expressed that many of the unique features of Eversense – its long-term use, removable transmitter and predictive, on-body vibe alerts – allow them to be more discreet as they manage their diabetes. In a recent analysis, we have seen that early Eversense users in the US have experienced 62% time in the target range for sensor glucose values of 70-180 mg/dL during their first sensor wear. This non-adjunctive dosing claim is yet another benefit for those patients who want to manage their diabetes with greater ease and freedom.”

The system was the winner of Medgadget’s 2016 Best Medical Technologies of 2016, and we’re glad that more patients will have access to this technology.

Flashbacks: Eversense Implantable Glucometer Keeps Tabs on Blood Sugar Continuously for 3 Months; Eversense 90-day Continuous Glucose Monitor CE Marked in Europe; Medgadget’s Best Medical Technologies of 2016

Product page: Eversense CGM

Via: Senseonics (1,2)