FDA Grants Oxehealth Vital Signs De Novo Clearance

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March 30, 2021

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.

Chief Executive of the company, Mr. 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.”

Company 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.”

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