OrSense wins CE approval

The company can now begin marketing its non-invasive glucose monitor in Europe.

Medical device start-up OrSense Ltd., which develops medical devices for non-invasive measurement of glucose using infrared technology, has received CE mark certification for its first product, the NBM 200G. The company can now begin marketing the product in Europe.

Many companies have tried unsuccessfully to develop non-invasive devices for monitoring blood glucose levels that would save diabetes patients from having to prick themselves in the fingers several times a day, thereby enabling more frequent testing and a better level of blood sugar monitoring. To date, a number of devices have been developed but all have failed efficacy trials on submission for US Food and Drug Administration (FDA) approval. At present, 10 non-invasive and minimally invasive technologies are in the early development stages, the most advanced of which are a minimally invasive technology developed by Abbott Laboratories (NYSE: ABT) and OrSense's device, both of which have now received CE market certification.

In general, the CE Mark is not an indicator of a device's efficacy but only of its safety, so it does not reflect the product's chances of being accepted on the market. OrSense CEO Lior Ma'ayan believes that the device's FDA trials will be longer and more complex, with approval due no earlier than the final quarter of 2008. In any event, the company does intend to begin marketing the device at present and will instead offer it for testing to a number of leading medical centers across Europe, in order to gather data ahead of a full launch, if and when FDA approval for the device is obtained.

Published by Globes [online], Israel business news - www.globes.co.il - on June 20, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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