LONDON, UK: Deltex Medical Group plc (AIM: DEMG), the global leader in oesophageal Doppler monitoring, has announced the UK and EU launch of its new next generation TrueVue System, a device that measures blood flow and pressure in real time across each heartbeat in a patient.

The launch follows the successful independent review of the electromagnetic compatibility (EMC) report on the new TrueVue monitor and the finalisation of the technical file, as announced by the Group on 6 July 2023. The new next generation TrueVue System has now received CE mark approval and is ready for in-hospital evaluations in the UK and EU, to ensure that there are no issues with the device before fulfilling any orders. The Group expects to start generating revenue from new monitor sales in November 2023, after completing the evaluations, which is expected to take about 3 months. This is a standard practice for any medical device, as it cannot be used in a hospital without CE mark approval.

The new TrueVue System provides the clinician with a range of clinically validated haemodynamic parameters, which are used to assess the patient’s cardiac function and guide fluid and drug therapy to optimise heart performance or normalise blood volume.

The new next generation TrueVue System is a major improvement over Deltex Medical’s existing system. The device is portable, battery powered, light-weight and has a much simpler user interface. The device can be used in adult and paediatric patients undergoing surgery or treatment in critical care departments, such as Intensive Care Units or High Dependency Units, or in Accident and Emergency.

The new next generation TrueVue System will also be the platform for the Group’s new non-invasive Suprasternal device, which is currently under development. This device will measure blood flow and pressure without inserting a probe into the patient’s oesophagus, making it suitable for awake patients in various settings, such as general wards, Accident and Emergency or by paramedics. The new next generation TrueVue System and the new non-invasive Suprasternal device are key to the Group’s future growth and long-term strategy.

Andy Mears, CEO of Deltex Medical, said: “We are very pleased to have launched the new next generation TrueVue System. This is a significant achievement considering the difficulties we faced due to Covid-19 and the supply chain issues.

I want to thank all our employees for their dedication and perseverance to get this done.

We have received positive feedback on the new monitor and we anticipate that the launch will boost our activity levels in all territories as we await other international regulatory approvals. We have been producing new monitors in preparation for starting to fulfil orders in November.”