• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Cellnovo files 510(k) for connected diabetes management system

November 16, 2016 By Sarah Faulkner

CellnovoCellnovo (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%.

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

IN CASE YOU MISSED IT

  • Glooko adds chief strategy officer to chief medical officer’s title
  • Cordis launches 10,000-patient registry for drug-eluting balloon
  • Senseonics opens $50M public offering, $25M private placement with Abbott
  • Study links Abbott CGM use to lower risk of hospitalizations due to heart complications
  • Go-Pen ApS wins FDA nod for user-filled insulin pen

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS