Senseonics' 180 | 合法醫療器材資訊網

2020年12月29日—Senseonics'planstorolloutitsnew,long-termdiabetessensorimplantwillbepushedtothemiddleofnextyearasFDAreviewerscontinueto ...

Senseonics’ plans to roll out its new, long-term diabetes sensor implant will be pushed to the middle of next year as FDA reviewers continue to be swamped by product submissions aimed at the COVID-19 pandemic.

The upcoming version of the Senseonics Eversense continuous glucose monitoring system—a smartphone-connected device, first approved[1] in June 2018, thats inserted completely under the skin—aims to double its life span from 90 days to six months.

But the company has received word[2] from the FDA to expect delays of at least two months for its application while the agency tasks its staff with emergency reviews of coronavirus tests and other medical devices, it said.

The setback matches what Senseonics has heard from other medtech developers currently trying to get their products reviewed, the company said, noting that theres still potential ...