German patient monitor developer Senzime said today it won CE Mark approval in the European Union for its TetraGraph neuromuscular monitor.
The newly cleared TetraGraph monitor is designed for use in the perioperative monitoring of physiologic data in surgical patients under general anesthesia and muscle relaxation using neuromuscular blocking drugs.
The system is designed to stimulate a peripheral nerve to measure, analyze and display muscle function in surgical patients who’ve received NMBAs as part of their general anesthesia.
“The CE mark is a major milestone for Senzime, we will immediately commence the market roll-out of the TetraGraph system initially in Europe followed by the US and rest of the world. The TetraGraph will allow physicians to monitor the effects of neuromuscular blocking drugs perioperatively and ensure that patients can breathe spontaneously which will prevent complications and hence lower healthcare costs,” CEO Lena Söderström said in a press release.
Senzime said it had previously inked general distribution agreements for the TetraGraph in the UK, Ireland, Switzerland, Australia and New Zealand with a licensing agreement in Japan.
The company added that it is in ongoing discussions with distributors for additional markets with expected deals coming during the following quarter.
“We look forward to use the TetraGraph routinely, since the device is very easy to use, saves us time with the quick set-up and provides invaluable clinical information,” Bela Fulesdi of Hungary’s Debrecen University Hospital said in a prepared statement.