ESYSTA’s Bluetooth insulin pen in CE approval process

Emperra GmbH E-Health Technologies announced a further development of its telemonitoring product system, ESYSTA, for insulin dependant diabetes patients.

The Bluetooth-enabled smart insulin pen and the ESYSTA diabetes smartphone app are almost ready for their market launch. Both components are in the last stages of the CE conformity assessment procedure and will be available as an extension of the ESYSTA product system on the European market expectedly from late summer 2015.

Emperra developed the ESYSTA Bluetooth pen to send data straight from insulin pen to smartphone app. The insulin pen, as well as the app, are currently under the CE conformity assessment procedure but will be available shortly.

Dr. Christian Krey, CEO of Emperra, said: “The further development of the already commercially available insulin-data transferring ESYSTA Smartpen to a Bluetooth enabled insulin pen is a logical step. By the direct transfer of the insulin data to a smartphone, a database is available at all times that will further simplify the treatment. First diabetes centers and health insurers have already expressed their interest in providing their patients with the  ESYSTA Bluetooth pen.”

Moving towards modern high-tech diabetes management systems, the development of a Bluetooth enabled insulin pen and the corresponding smartphone software could address patients, who prefer the latest technological solutions on mobile devices and would like to use the immediately available data for their self-management.

Krey said: “Emperra is planning to offer this integrated Bluetooth solution, in compliance with CE standards, as a medical device to the European market late summer and will thereby continue to be the main innovation driver especially for smart insulin pens and integrated diabetes solutions.

ESYSTA, the first validated plug and play diabetes management system, that uses a transmitting insulin pen, which automatically transfers the data, is already available on the market and is reimbursed by health insurances. The addition of a Bluetooth-based insulin pen enables the expansion of the target group of type 1 and type 2 diabetics to those who would like to have mobile access to their insulin data.”

Dr. med. Janko Schildt, founder and general manager responsible for medical science and technology, said: “The use of ESYSTA saves all users a considerable amount of time: this goes for the patient as well as their private and medical setting. With the existing and future further product developments, we are convinced to reach an even wider target group and to carry on supporting digital health care within reasonable costs in the patients'- physicians- and  nursing staffs' interest.”