SciBase receives IDE approval from FDA

SciBase has received IDE approval from FDA for the pivotal study that will be performed in 2010 to create scientific evidence about the methods accuracy.

The IDE (investigational Device Exemption) approval allows SciBase to perform the clinical study in Europe and the US at up to 25 clinical institutions.

Please read the attached press release for more information:

About Us

SciBase is a Swedish medical technology company founded in 1998 that has developed Nevisense, a point-of-care device for the accurate detection of malignant melanoma. Nevisense has emerged from more than 20 years of research at Karolinska Institute in Stockholm and at SciBase. The device is designed to be provide additional information when evaluating lesions with a suspicion of melanoma. Nevisense is based on a technology called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. The CE-marked system consists of an electrode on a hand-held probe connected to a small portable device performing the analysis and displaying the result. A video describing the Nevisense method is available on: www.scibase.se/en/the-nevisenseproduct and further information is also available on www.scibase.com.

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