Vinehealth, a UK digital health tech company, has received a Class 1 Medical Device CE mark for its Vinehealth Cancer Companion mobile application for patients and its VinehealthPRO web application for clinicians.
Vinehealth conforms to the requirements of the Medical Devices Directive 93/42/EEC. The Directive outlines safety and performance requirements for medical devices in the UK & EU.
Vinehealth’s platform combines behavioural science and artificial intelligence to increase the quality of life of cancer patients. The Vinehealth mobile app allows cancer patients to track, manage and understand their care, supporting them to feel in control and better self-manage. The VinehealthPRO web application is used by healthcare professionals to support clinical decision making and inform the development of cancer therapeutics within clinical trials.
This is a momentous achievement for Vinehealth who, after only two years of being founded, continue to make waves throughout the digital healthcare industry. The CE mark will enable Vinehealth to enhance the features in both their applications and deliver value to patients, healthcare professionals and life science partners alike.
Ravi Khiroya, Vinehealth’s Product Owner, commented:
“I am immensely proud of the whole team’s contributions towards achieving our Class 1 CE mark. It has been challenging but we have learnt so much – a testament to our commitment to delivering the best possible product to our users and ensuring their welfare is our highest priority.”
To gain the CE mark, Vinehealth worked with regulatory professionals to complete the complex processes required.
Vinehealth’s CTO Georgina Kirby commented:
“CE marking our software as a medical device whilst maintaining the ability to move fast and innovate was a challenging process. We had to critically think about our entire product development process and create a Quality Management System that would meet medical device standards in the UK, Europe and the US.
“We achieved this in record time thanks to our incredibly talented team. I’m hugely proud that this teamwork and dedication ensured we met the high standards of safety needed to obtain a CE mark.”
This achievement is just another step towards Vinehealth transforming the delivery of cancer services and outcomes for people living with cancer.