Here is their press release: http://www.asantesolutions.com/userfiles/file/COL-1015%20Rev%20A%20-%20510(k)%20Press%20Release.pdf
“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,”
“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.”
Pretty cool to have another option on the market soon.