Vision-based patient monitoring service Oxehealth has been granted De Novo clearance by the US Food and Drug Administration for its Oxehealth Vital Signs product, which is incorporated into Oxevision.
The grant means Oxehealth can place Oxevision on the market in all US states, where it will focus on deployment into skilled nursing facilities (“SNFs”). There are more than 15,500 SNFs across the US, that care for more than 1.35 million people who do not need to be in hospital.
Oxevision, which is delivered as part of the Oxehealth Service, has been shown to help clinicians within UK and European healthcare organisations to improve the safety, quality and efficiency of their care.
Chief executive Hugh Lloyd-Jukes said: “Oxehealth secured a world first accreditation for its technology when it obtained European medical device certification two years ago.
“It is a tribute to the hard work of our development teams and our clinical research partners that our Vital Signs technology has now been cleared by the FDA in another world first that has created an entirely new category of medical solution: vision-based patient monitoring and management.
“This is an exceptional achievement for Oxehealth, and we are excited that we can now begin partnering with clinicians and the leadership teams of healthcare providers in America to enable them to deliver safer, higher quality and more cost-efficient care.”
Oxehealth was founded by the former Dean of Engineering at the University of Oxford, Professor Lionel Tarassenko, in 2012, with the aim of creating a system for the measurement of pulse and breathing rate without the need to attach a device or wires to a patient’s skin.
Oxevision delivers on that ambition. It enables staff to intervene to prevent incidents such as falls and assaults by alerting them to early warning signs; to take accurate visual and vital sign nursing observations without disturbing patients; and to improve care planning by accessing activity reports and reviewing incidents.
Lloyd Jukes added: “Our evidence demonstrates that deploying the Oxehealth Service leads to an immediate step change in care outcomes and staff and patient experience.
“As significantly, our partners see year on year continuous improvement in their service, with staff making use of the time saved and insights received, to plan care and develop more efficient and effective ways of working.
“That means that, unlike conventional remote patient monitoring devices, such as bed mats, falls monitors or wearables, the Oxehealth Service delivers on the promise of minimising patient harm, maximising patient recovery, and making it possible to reconfigure patient pathways.”
As well as serving US SNFs, Oxehealth will make Oxevision available to the wide range of provider organisations that have already benefited in the UK and Europe, including: assisted living facilities, general hospitals, behavioural health providers and custodial care settings.
