Tensys Medical lands FDA clearance for its TL-300 non-invasive hemodynamic patient monitoring system.
San Diego-based Tensys Medical this week won FDA clearance for its next generation TL-300 hemodynamic patient monitoring system.
The non-invasive TL-300 device provides physicians with a stream of real-time patient waveform and blood pressure data in a manner the company says isn't possible with traditional non-invasive devices.
The device gathers hemodynamic information from an integrated bracelet, sensor, and wrist frame, which is then displayed on a tablet-friendly touch-screen monitor.
"The TL-300 represents our continued commitment to delivering next generation, non-invasive, hemodynamic monitoring tools," Tensys' medical director Dr. Oliver Goedje said in prepared remarks. "This new system will not only enhance our current product offering, but will serve as a platform as we add cardiac output and additional hemodynamic parameters in the near future."
The TL-300 is the latest in Tensys' T-Line family of devices, which have been successfully used in over 50,000 patients since hitting the market, according to the device maker.
Tensys plans to unveil additional details about the newly approved device at the upcoming 2013 OneMedForum in San Francisco, Calif., the company said.
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