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# Voluntis 510(k) for Insulia Cleared by FDA
- URL: https://www.fdaweb.com/voluntis-510-k-for-insulia-cleared-by-fda/
- Published: 2017-11-16T12:00:00.000Z
- Updated: 2026-09-14T23:02:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140155

FDA has cleared a Voluntis 510(k) for Insulia, a “digital companion” for people with Type 2 diabetes that the sponsor says can integrate Lilly’s Basaglar and Novo Nordisk’s Tresiba insulin products. According to the company, this now makes Insulia available for people using any brand of basal insulin including Lantus, Levemir, Toujeo, Tresiba and Basaglar. Voluntis says it is planning to make Insulia available for other insulin therapies, including NPH insulin and GLP-1/basal insulin combinations sometime next year.

  
Insulia helps patients determine the correct insulin dose, it says. The device combines a patient mobile app and health care practitioner Web portal to provide real-time basal insulin dosing recommendations and educational coaching messages based on blood glucose values, according to the company.