FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Senzime’s OnZurf Probe Scores CE Mark

Dec. 26, 2017

Senzime’s OnZurf Probe device received CE Mark approval within Europe, with an initial direct sales period in Scandinavia planned.

The device is intended for use after gastrointestinal tract procedures. It is able to continuously collect organ surface samples, which can be analyzed either intermittently or continuously, according to the announcement.

The device can monitor postsurgical healing and flag warning signs of post-operative complications. The company anticipates CE approval for its corresponding analyzer by the second half of 2018.

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