Senseonics nabs CE mark for extended-life CGM

Senseonics' newest implantable sensor may be used for up to 180 days, compared to the one- or two-week limits of its competitors' sensors. (Senseonics)

Senseonics received a CE mark for its longer-lasting continuous glucose monitoring system. The new system has a glucose sensor that lasts up to 180 days, double the life of the system it already markets, which has a sensor that may be used for up to 90 days.

In addition to the long-term implantable sensor, the Eversense XL Continuous Glucose Monitoring System comprises a transmitter and a mobile app that displays real-time glucose data. The company plans to roll the product out in Europe in the fourth quarter this year, according to a statement.

The 90-day version of Eversense earned a CE mark in May last year. Senseonics anticipates FDA clearance for the device later this year, CEO Tim Goodnow said on the Q2 2017 earnings call.


Webinar: The Key to Continuous Compliance for Medical Device Software Developers

Risk is not an option in medical device software development. You need to mitigate time-to-market, FDA, and security risks, or you could be facing a costly recall or software update. Attend this webinar to learn how to use static analysis to ensure continuous compliance with industry standards and regulatory requirements, improve security for increasingly connected medical devices, and enforce corporate and industry coding rules and best practices.

RELATED: The top companies in medtech by 2016 revenue - Roche

“When we introduced the Eversense System last year, we were providing the longest-wear sensor with up to 90-day wear for people with diabetes,” Goodnow said in the statement. “Now with the new Eversense XL System’s even longer sensor duration, patients can extend a single sensor wear over 3 seasons—inserting a new sensor in the Fall which will continue through the Winter to be replaced in Spring."

Shortly after the 90-day Eversense snagged its CE mark, Germantown, MD-based Senseonics signed a distribution deal with Roche, where the Swiss pharma would market the device in Germany, Italy and the Netherlands.

The pair extended their partnership in July, when Roche joined Senseonics and TypeZero Technologies in the development of a long-term, closed-loop system for blood glucose control. The system will combine Roche’s Accu-Chek insulin pump, Senseonics' 90-day sensor and TypeZero's inControl software.

Suggested Articles

Cornell researchers found that inhibiting a long noncoding RNA called SAF caused HIV-infected cells to self-destruct.

Liquid biopsy developer Epic Sciences has brought on Myriad Genetics’ oncology chief, Lloyd Sanders, to be its new president and CEO.

Thermo Fisher Scientific has moved to acquire viral vector developer and manufacturer Brammer Bio for $1.7 billion in cash.