FDA grants 510(k) clearance to Asante's Pearl Insulin Pump

Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the company's Pearl Insulin Pump. Last month, the Pearl also received the CE Mark, a European proof of conformity that certifies the product meets EU safety, health and environmental requirements.

"We are pleased to accomplish these important regulatory milestones, and we are particularly proud to be the first fully-programmable insulin pump cleared under the FDA's new more comprehensive and stringent infusion pump guidelines," said Phil Hopper, Asante's CEO and president. "These milestones validate our sensible approach to solving some of the fundamental challenges faced by more than 500,000 people worldwide who use an insulin pump or are considering insulin pump therapy. These clearances now allow us to focus on establishing the capabilities necessary to provide world class operations and customer service as the product becomes available."

"The Pearl Insulin Pump's utilization of a pre-filled insulin cartridge is an evolutionary step forward for those on intensive insulin therapy," said James Chamberlain, MD, medical director for Diabetes Services at St. Mark's Hospital and St. Mark's Diabetes Center. "The fact that the Pearl minimizes all the 'plumbing' issues associated with reservoir filling in other insulin pumps makes it an attractive choice as a starter pump for those initiating insulin pump therapy as well as for those seeking greater ease of use. The Pearl is designed to reduce steps, add convenience, and save time."