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FDA Clears Calibra Finesse Insulin Patch-Pen For Three-Day Use With Novolog

Calibra Medical has received FDA 510(k) clearance to market its Finesse insulin patch-pen for up to three-day use with Novo Nordisk's Novolog rapid acting insulin.

Calibra’s bolus-only patch-pen is a small, adhesively attached, flat device that can be operated discretely through clothing to deliver mealtime, snack time, and correction bolus insulin in seconds .

Calibra said that the Finesse design helps diabetic patients to avoid the inconvenience and the social challenges of daily mealtime injections with needles. It represents a new category of simple mechanical devices making insulin therapy adherence easier to achieve at an affordable price.

Reportedly, in January, Calibra Medical has received FDA clearance for the device for use with Eli Lilly’s Humalog rapid acting insulin. The company has been pursuing marketing clearance for Finesse to deliver other manufacturers’ insulin and diabetes drugs, and is planning to develop models, including devices pre-filled with insulin.

Jeffrey Purvin, chairman and CEO of Calibra Medical, said: “Finesse will be easy for physicians and diabetes educators to explain to patients. Most patients want to eliminate the social embarrassment, elaborate preparation before each dose and the many daily needle sticks required by syringes and insulin pens. Like expensive insulin pumps, Finesse provides fast, discreet, needle-free dosing. Yet, it accomplishes this with the simplicity, safety and affordability of syringes or insulin pens.”

Nancy Bohannon, a practicing endocrinologist and director of clinical research at the Cardiovascular Risk Reduction Program, St Luke’s Hospital, San Francisco, said: “With this device people will find daily self-administration of multiple doses of insulin is far easier, with less disruption and increased potential for better diabetes control.”