The FDA has given its okay to Companion Medical’s InPen delivery system, which the company touts as the first U.S.-approved Bluetooth-enabled insulin pen.
The San Diego-based company’s device includes technology that can calculate and recommend the best dosing for patients, track the history and timing of doses, monitor insulin temperature, report information to health-care providers, and is compatible with Eli Lilly's ($ELY) Humalog or Novo Nordisk's ($NVO) Novolog rapid acting insulins.
A little over a year ago Lilly led a round of Series B financing for Companion, and gained a seat on the company’s board.
"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,” Sean Saint, Companion’s CEO, said in a statement.
The device also passed its InPen app for Apple iOs and the company said an Android version will be available in the coming months. Companion has also filed for a CE Mark for the device in Europe.
Last week, the FDA asked Sanofi for more information on its device designed to deliver its Lantus-plus-lixisenatide combo to combat diabetes. The move by the regulatory agency essentially pushes the approval decision back by about three months, giving Novo Nordisk ($NVO) the advantage to get its diabetes combo that pairs its basal insulin Tresiba with the GLP-1 blockbuster Victoza to market first.
Companion's approval, which is seen as an advancement in insulin delivery, was almost lost in the tumult surrounding costs associated with Mylan’s ($MYL) EpiPen. Prices for that device--which is a staple for people, especially children, who have severe allergies--have soared 480% since Mylan acquired its maker in 2007.
- here’s Companion’s release
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