Companion Medical Receives FDA OKA for Smart Insulin Delivery SystemBy
Companion Medical, a San Diego, California-based company focused on advanced technology to improve diabetes care, has been granted 510(k) clearance by the US Food and Drug Administration for the InPen system, its wireless-enabled insulin pen and proprietary mobile application.
The InPen includes technology to: calculate and recommend optimal dosing; track history and timing of doses; monitor insulin temperature; display last dose and insulin-on-board; and track and report to the health care provider.
Companion Medical’s InPen is cleared in the US for use with Eli Lilly and Company's Humalog or Novo Nordisk's Novolog rapid acting insulin. The InPen app is cleared for Apple iOS with an Android version planned for late 2016. The company has also filed for CE Mark.
Source: Companion Medical