Senseonics, a Germantown, Maryland-based company working on a longterm implantable continuous glucose monitor, has received a CE Mark for its Eversense Continuous Glucose Monitoring (CGM) System.
“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” Senseonics CEO and President Tim Goodnow said in a statement. “The approval enables the company to market and sell the Eversense System in European Union (EU) member countries, and we are prepared to make this important medical device available to people with diabetes.”
Senseonics' offering is a pill-sized sensor that is entirely implanted in the user’s upper arm so that it can continuously monitor their glucose levels. The device is meant to last at least 90 days before it needs to be replaced — in contrast to the five to seven days that current not-quite-so-invasive CGMs last.
Goodnow said the company would begin commercialization in Sweden in partnership with the company’s exclusive distributor, Rubin Medical.
According to company, the system is indicated for continuous measurement of interstitial fluid glucose levels in adults. The device is also indicated to be used as an adjunctive device that will complement information collected from standard home blood glucose meters. Senseonics will conduct post market surveillance that includes collecting long-term safety and performance data from repeated sensor insertions.
Earlier this year, in January, Senseonics with an IPO that, at the time was valued at $51.75 million. A month later, with diasend, a Swedish diabetes data management company, to maximize the user experience of its device, and to establish a pipeline for sending its data to users’ healthcare providers.