The US Food and Drug Administration (FDA) has granted 510(k) clearance to Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system, designed for use in operating rooms, intensive care units and electrophysiology labs.
The TL-300 system utilises Tensys' T-Line technology to accurately and continuously capture a patient's beat-to-beat waveform and blood pressure in a non-invasive fashion, which is not possible using traditional non-invasive blood pressure (cuff) devices.
Avoiding the blind-time associated with a deflated or inaccurate non-invasive blood pressure cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes, according to the company.
In addition to continuous beat-to-beat blood pressure and arterial waveform, the operator is able to view data trends for up to a 12-hour period.
Featuring a tablet-supported monitor that allows touch screen control, the system displays real-time hemodynamic data from an integrated bracelet, sensor and wrist frame placed over the patient's radial artery.
The wrist frame is disposed of at the end of the case, and the bracelet and sensor are immediately available for the next patient.
Tensys medical director Dr Oliver Goedje said; "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."