Asante Solutions has announced that their Pearl Insulin Pump has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) and has now been approved for sale in both the U.S. and the European market. The insulin pump is based on a technology invented by the Dane Morten Mernøe and the company has received significant investment from the largest Danish venture funds as well as two U.S. funds.

Current insulin pumps on the market require the user to manually fill an insulin pump reservoir every 2-3 days. Besides being inconvenient for the individual user there is an improved risk of air bubbles and defects which may have serious consequences if not detected. Pearl is designed to use a standard insulin glass ampoule with capacity for 300 units deployed in a disposable pump unit. The user can thus use the pump for up to seven days without either measuring insulin or refilling unit. Thus Pearl Insulin Pump is designed to improve daily life significantly for the many people who because of their diabetes is in intensive insulin therapy.

Pearl pump is the first programmable insulin pump that gets FDA approval using the new and more stringent guidelines for infusion pumps. Last month the pump was also CE marked - the European license showing that a product complies with EU requirements for safety, health and environment - which gives permission to market the product in Europe.

“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.”

"Pearl is a great example of user driven innovation. In this case the need for an easier handling without compromising safety. Also it is very valuable that is is device with a disposable pump and a very pricefriendly controller, which reliefes the user of a pricy initial purchase" says Ulla Brockenhuus-Schack from SEED Capital.