Deltex Medical Group Gains FDA Approval

Medical devices firm Deltex Medical Group has received approval to launch its CardioQ-EDM monitor in the US by the country’s Food and Drug Administration.

Deltex is now able to market and sell the device in the US with immediate effect, it announced today.

Cardio-EDM is similar to CardioQ-ODM (oesophageal Doppler monitor) – Deltex’s blood monitoring system that requires a new disposable probe every time the system is used on a new patient, meaning that Deltex gets a consumables-driven revenue stream as well as income from sales of the device itself.

According to Deltex, CardioQ-EDM offers a number of user interface and patient management enhancements over its predecessor. The key additional benefits come from increased data-sharing capability, allowing the monitor to integrate more closely with hospital systems as well as enhanced tracking and downloading of patient responses to interventions guided by the system.

“The FDA approval is welcome news and means we can now plan to introduce the enhanced functionality of the CardioQ-EDM to our existing US customers and prospects,” says Ewan Philips, Deltex’s chief executive. “In particular, this generation of monitor makes it easier for doctors to collect the patient and intervention data necessary to participate in projects designed to demonstrate the significant potential impact on US surgical outcomes from our technology.”