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FDA approves Lilly-backed Bluetooth insulin device

Clears Companion Medical’s Bluetooth-enabled pen and smartphone app

Digital pharmaUS regulators have cleared a Bluetooth-enabled insulin pen and associated smartphone app from Companion Medical.

The San Diego-based medical device firm last year received funding from Lilly, with the pharma company gaining a seat on Companion's board. The FDA approved Companion's InPen system for use with Lilly's Humalog or Novo Nordisk's Novolog rapid acting insulins and also passed its InPen app for Apple iOS.

The company plans to release an Android version later this year and has also filed for a CE Mark (kitemark) in Europe.

Sean Saint, Companion Medical's chief executive officer, said: "FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care.

"The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally."

23rd August 2016

From: Sales

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