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Cellnovo

Cellnovo, Diabeloop launch artificial pancreas CE Mark trial

April 21, 2017 By Fink Densford

Cellnovo, Diabeloop

Cellnovo (EPA:CLNV) and Diabeloop said this week they are launching a CE Mark cross-over registration study for an artificial pancreas device Diabeloop is developing which uses Cellnovo’s insulin pump. The registration study aims to generate appropriate security & safety data as the company seeks CE Mark approval for the Diabeloop artificial pancreas combined with Cellnovo’s CGM some […]

Filed Under: Clinical Trials, Diabetes, Featured Tagged With: Cellnovo, Diabeloop

Cellnovo files 510(k) for connected diabetes management system

November 16, 2016 By Sarah Faulkner

Cellnovo

Cellnovo (EPA:CLNV) said today that it has filed for 510(k) clearance from the FDA for its diabetes management system. Paris-based Cellnovo touts its system as the 1st mobile, connected diabetes management system. Tubeless and compact, the company’s insulin pump has a mobile touchscreen controller with an integrated blood glucose meter. Data from insulin injections and blood-glucose levels are […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), mHealth (Mobile Health), Regulatory/Compliance Tagged With: Cellnovo

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