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Calibra Insulin Patch-Pen Receives 510(k) Clearance

Calibra Medical has announced that the FDA has cleared Finesse, the company’s insulin patch-pen. Calibra’s Finesse is the first of several non-electronic devices under development by the company that simplify mealtime insulin delivery.

Measuring roughly 2” long, 1” wide and ¼” thick, Finesse is a small plastic device designed to adhere to a patient’s skin. Finesse is able to hold and deliver prescribed amounts of insulin over multiple days while remaining firmly in place throughout a patient’s daily activities, including showering, exercising and sleeping. Finesse is operated discreetly through a patient’s clothing and is designed to quickly deliver many common dose amounts, claims the company.

Jeffrey Purvin, chairman and CEO of Calibra, said: “Finesse combines the fast, discreet, needle-free features of wearable insulin pumps with the non-electronic simplicity, safety and affordability of insulin pens. Most syringe and pen users wish their insulin delivery devices didn’t require so many daily needle sticks and were faster and easier to use. Finesse addresses each of those desires.”

The company has already initiated a clinical trial involving 6 major sites in the US.