US-based Tensys Medical has received Chinese State Food & Drug Administration (SFDA) approval for its next-generation continuous, non-invasive hemodynamic patient monitoring system.
In February 2013, Tensys Medical entered into the exclusive commercial agreement with Zhejiang Shanshi Medical Device (Shanshi) for T-Line distribution in China, Hong Kong and Taiwan.
Under the terms of five-year exclusive supply relationship, both companies agreed on cumulative orders of up to $40m in TL-300 sales.
The SFDA clearance will allow Shanshi to begin immediate commercialisation in China with initial focus on the operating room (OR) and intensive care unit (ICU) markets.
Shanshi general manager Dr Xiaodong Du noted that the company is pleased to have received SFDA approval so it can immediately begin selling and capitalising on the high level of interest in the TL-300 seen throughout its pre-commercial marketing efforts.
"We are confident that the TL-300 represents the future of hemodynamic monitoring in the Chinese market," Dr Du added.
The non-invasive TL-300 features a tablet supported monitor that allows touch-screen control and displays a patient’s key hemodynamic data streaming from an integrated bracelet, sensor, and wrist frame placed over the patient’s radial artery.
The monitoring device provides physicians with a stream of real-time beat-to-beat blood pressure and arterial waveform data in a manner that it is not possible with other non-invasive blood pressure devices.
The operator can also easily analyse the trend data for up to a 12-hour period.
The bracelet and sensor can be used immediately for the next patient after the wrist frame gets disposed at the end of the each case.
Tensys sales and marketing vice president Dr Eric Daniels noted that the company is delighted that its TL-300 system has received marketing and sales approval for the Chinese market.
"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," Dr Daniels added.