Patient monitor developer Senzime said today it won CE Mark approval in the European Union for its OnZurf probe designed for various gastrointestinal tract surgical procedures.
The German company’s OnZurf probe is designed to continuously collect samples from the surface of an organ which can be analyzed intermittently by an external analyzer or continuously through the company’s CliniSenz analyzer.
The probe is designed to monitor local metabolic changes to detect complications before they become systemic. Senzime touts the OnZurf device as having the unique ability to monitor a patient’s healing process after surgery to provide early warnings of post-operative complications including lack of oxygen.
“Continuous sampling in patients undergoing surgery may provide an opportunity to detect early complications. The clinical market seeks products that allow continuous sampling and monitoring of tissue substances to detect complications after surgery and control interventions. The CE mark of OnZurf Probe is an important milestone for Senzime and we will immediately initiate launch in Europe” CEO Lena Söderström said in a press release.
The OnZurf device is being trialed in several clinical studies, including continuous monitoring trials with the company’s CliniSenz, which the company is hopeful will receive CE Mark approval during the second part of 2018.
Last week, Senzime said it won CE Mark approval in the European Union for its TetraGraph neuromuscular monitor.