Remote Diagnostic’s Tempus Pro medical monitor gets FDA 510(k) clearance

24 September 2014 (Last Updated September 24th, 2014 18:30)

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

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

Tempus Pro will be used as a stand-alone monitor or as a telemedicine system, and is indicated for adults, paediatrics and neonates.

The system is a portable vital signs monitor, which has been developed for 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 be used in applications such as 12 Lead ECG recording interpretation, real-time arrhythmia detection, ST and QT monitoring and alarming.

"Tempus Pro, which will be used as a stand-alone monitor or as a telemedicine system, is indicated for adults, paediatrics and neonates."

Tempus Pro can also be used to determine invasive blood pressure with capabilities of Masimo rainbow SET 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 Systems Engineering and Test director Dr Leigh Cornock said: "These advances demonstrate RDT's commitment to ongoing development of the Tempus Pro transport monitor, launched in June last year.

"Expanding the monitor's capabilities to include 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.

"As such, we believe Tempus Pro sets a new benchmark in pre-hospital vital signs monitoring and that the bar has been raised yet again."

Compared with other pre-hospital transport monitors on the market, the system provides all of the Masimo rainbow functions. Addition of all six measurements represents a significant step, providing clinicians with a high level of real time information to help them take informed clinical decisions.

Masimo rainbow extended pulse oximetry allows continuous and immediate measurements of blood constituents and fluid responsiveness non-invasively.

The company's clearances include: PVI, PI, carboxy haemoglobin (SpCO), metheglobin (SpMet), total haemoglobin (SpHb) and total oxygen content (SpOC). Earlier, the Tempus Pro medical monitor also received CE and other market approvals.