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 automatically transmitted using Cellnovo’s connected system, allowing healthcare professionals to continually monitor the patient’s condition in real time. The device offered superior accuracy in insulin delivery when compared to other compact wearable systems in a peer-reviewed publication, according to the company.
“We are pleased to have submitted our application to the US authorities. The United States represents an important future market for Cellnovo with 1.25 million children and adults with type 1 diabetes,” CEO Sophie Baratte said in prepared remarks. “Furthermore, market penetration of insulin pumps is higher in the US than anywhere else in the world. We believe that our diabetes management system, offering unrivaled levels of freedom and connectivity combined with high levels of accuracy, has the potential to perform strongly in the growing insulin-pump marketplace.”
CLNV shares were trading at $6.18 apiece in mid-morning activity, up 4.6%.
