FDA grants Oxehealth Vital Signs De Novo clearance
Oxehealth has announced another world first after the US Food and Drug Administration granted a De Novo clearance for its Oxehealth Vital Signs product, which is incorporated into Oxevision, the vision-based patient monitoring and management platform delivered as software as a service.
Oxehealth Chief Executive Hugh Lloyd-Jukes said, "Receiving a de novo FDA clearance and creating an entirely new category of medical device is an exceptional achievement for Oxehealth. 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 Chairman James Ede-Golightly said, "Oxevision has supported the provision of over 5 million hours of patient care. Approaching 40% of English Mental Health Trusts rely on Oxevision to support the work of their clinical teams. Our experience in the UK and Swedish markets positions us strongly for success in the US market."
Oxehealth is a vision-based patient monitoring and management company. We help clinicians to deliver safer, higher quality and more cost-efficient care in inpatient and residential care settings.
Our Oxevision platform enables staff both to plan patient care and to intervene proactively to help patients.
Unlike conventional remote patient monitoring companies, Oxevision includes a contact-free optical sensor which detects patient vital signs and behaviour and delivers a secure on demand video feed.
Oxevision provides staff with a wider range of clinically validated early warning signs and risk factors than any competing technology, plus the ability to check the patient visually before choosing their intervention.
Our Oxehealth Service supports customers to deploy the Oxevision platform and to use it to create proactive, data-enabled systems of care that deliver not only a step change on deploying the system but also year on year continuous improvement in safety, quality and cost efficiency.
Patients benefit from improved care outcomes, better sleep and more privacy.
Staff have more time to care, greater peace of mind and the chance to use improved clinical insights to work "at the top of their band".