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FDA grants 510(k) approval for RTD’s Tempus Pro medical monitor

UK-based Remote Diagnostic Technologies (RTD) has secured 510(k) approval from the US Food and Drug Administration for its Tempus Pro medical monitor.

Tempus Pro, which is designed to be used as a stand-alone monitor or as a telemedicine system by adults, paediatrics and neonates.

The system is a portable vital signs monitor, which has been developed to use by clinicians and medically qualified personnel for the attended or unattended monitoring of single and multiple vital signs in clinical and pre-hospital care applications.

The approval will allow the system to use in 12 Lead ECG recording interpretation, real-time arrhythmia detection, ST and QT monitoring and alarming.

It can also be used to know invasive blood pressure, as well as features capabilities of Masimo rainbowSET co-oximetry, video laryngoscope and ultrasound.

The system now offers four channels of invasive pressure, which can be used by critical care users such as CCATT teams.

RDT engineering and test system’s director Leigh Cornock said the advances demonstrates firm’s commitment to on-going development of the Tempus Pro transport monitor, launched in June last year.

"Expanding the monitor’s capabilities to included video laryngoscopy and ultrasound demonstrate RDT’s proposition of providing users with the ability to leverage more capability from the box they are already carrying," Cornock added.

Earlier, the system also received CE and other market approvals.