Sphere Medical, a developer of monitoring and diagnostic products for the critical care setting, has successfully completed an extensive Proxima system usability study at the Queen Elizabeth Hospital, Birmingham, UK.
These positive findings from the usability study form an important part of the dossier for CE Marking of Proxima.
Results from the study found that all of the usability targets for the Proxima system were met and that of the 50 participants that rated the system, 42 said it was either ‘Very Easy’ or ‘Easy’ to use while eight were ‘Neutral’ on ease of use.
During the study, anesthetists, ICU nurses and operating department practitioners were trained for one hour in the use of the Proxima system before being assessed on their ability to operate the device under both ICU and operating theatre conditions.
Following receipt of CE Mark authorization, Sphere Medical intends to launch Proxima in the UK, initially in key strategic UK teaching hospitals and subsequently in targeted clinical application areas suitable for early adoption of the Proxima system.
Sphere Medical CEO Stuart Hendry noted the company delighted with the results from this study.
"The clinical usability of our Proxima medical device design is hugely important to its commercial success once it reaches the marketplace.
"Furthermore, the successful completion of the study is an important additional milestone towards achieving CE marking of Proxima.
"Today’s news further de-risks Proxima and is another step closer to the launch of Proxima in the UK which we are planning for the first half of next year," Hendry added.