Tensys Medical has obtained State Food & Drug Administration (SFDA) approval for its new continuous, non-invasive hemodynamic patient monitoring system in the People’s Republic of China.
The TL-300 T-Line system comprises of a sensor, bracelet, wrist frame, and a tablet monitor to form an integrated system.
TL-300 monitoring system utilizes Tensys’ T-Line technology to accurately and continuously capture a patient’s beat-to-beat waveform and blood pressure in a non-invasive fashion that is not possible with other available conventional devices.
The SFDA clearance will allow Tensys’ local partner, Zhejiang Shanshi Medical Device (Shanshi), to begin immediate commercialization in China.
Pursuant to the terms of the five-year exclusive supply agreement, Shanshi has promised Tensys a minimum of $40m in TL-300 sales.
Shanshi will initially focus on the Chinese operating room (OR) and intensive care unit (ICU) markets.
The new generation TL-300 consists of a touch screen control and displays a patient’s key hemodynamic parameters.
The operator can view trend data coming from an integrated bracelet, sensor, and wrist frame placed over the patient’s radial artery for up to a 12-hour period.
The wrist frame can be disposed at the end of the case and the bracelet and sensor can be made available for the next patient.
Tensys sales & marketing vice president Dr Eric Daniels said, "This approval represents a significant achievement in our expansion to the Asian markets and strengthens our leadership position in the field of non-invasive hemodynamic monitoring."