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Diabeloop earns CE mark for artificial pancreas system

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Diabeloop recently received CE marking for the DBLG1 hybrid closed-loop system, the second so-called artificial pancreas to receive such a designation in Europe, according to a press release from the company.

The DBLG1 hybrid closed-loop system connects DexCom’s G6 Continuous Glucose Monitor, Kaleido’s patch insulin pump and an algorithm to a user’s phone to predict blood glucose levels and command the insulin pump at an optimal rate, according to the company.

“We are proud to have passed the regulatory step of the CE marking,” Erik Huneker, co-CEO and founder of Diabeloop, said in the release. “Our commercial deployment will be gradual in order to ensure quality of our product and our service towards the patients. We will also keep working for the reimbursement of our system as soon as possible.”

The company now plans to move towards a new funding round to support international scaling of the system, according to Marc Julien, co-CEO and CFO of Diabeloop.

“We hope to do all that by the second quarter of 2019,” Julien said in the release.

Currently, the only FDA-approved hybrid closed-loop system is the Medtronic 670G. The Omnipod Horizon system (Insulet) and Tandem Control IQ system are both in development.