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Received CE Mark Certificate isn't Enough, iXensor Aims at FDA Approval

By Vincent Wang
Published: Feb 09,2015

PixoTest system directly turns the smartphone into part of the PixoTest system(source:iXensor)

TAIPEI, Taiwan — iXensor Co., established in 2012 by three STB fellows (Standford-Taiwan Biomedical Fellowship program) , the company is dedicated to providing simple and practical solutions for mobile healthcare. The PixoTest, a blood glucose monitoring system is a flagship of the company and has just received CE Mark Certificate, and is applying for FDA approval.

PixoTest system is iXensor's first product. Unlike other mobile glucose monitoring systems that provide only data management or wireless/wire connection to the blood glucose meters(BGMs), the product directly turns the smartphone into part of the PixoTest system. Therefore, all the procedures are seamlessly merged together: the measurement, data analysis, and cloud-based services.

The company announced it received the approval of CE mark in July, 2014. The approval of CE mark for the self-monitoring glucose system, PixoTest and its smartphone app, PixoHealth, is significant for initiating market in Euripe by the end of 2014. iXensor aims to introduce the simpler way of testing blood glucose for self controlling and management of diabetes.

However, the company is yet applying for FDA approval in a bid to penetrate the American market.

iXensor invents the unique all-in-one platform that iXensor plans on expanding into other tests such as Cholesterol, uric acid and cardiac enzymes. iXensor plans to share a brand new vision of what mobile health can do for glucose monitoring.

Integrating hardware into a cloud-based software platform and then provide users high-efficiency health information for a better quality of life will be the mission and vision of iXensor. PixoTest system is selected as one of the best six companies in the eHealth Venture Summit and Innovation Award in MEDICA 2014. The company presented the system at MEDICA 2014 in Dusseldorf, Germany.

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