Oxford Heartbeat is awarded CE marking
London, 16 March 2020 – Oxford Heartbeat’s innovative, AI-powered software, PreSize® Neurovascular, has been certified to meet the health, safety and environmental protection standards for products sold within the European Economic Area (EEA). Obtaining regulatory approval from the British Standards Institution (BSI) in the form of a CE mark is a major accomplishment that enables Oxford Heartbeat to enhance the accuracy and precision of high-risk brain stenting surgeries throughout the European region. On top of the CE Mark, Oxford Heartbeat also received a full ISO13885:2016 certification as a medical device company from BSI.
Being awarded a CE mark in the “Class I Measuring” category, the innovative technology behind PreSize® defies stereotypes of how medical devices generally look. While PreSize® functions as a medical device, evoking the visual image and simulated behaviour of a hardware product, it takes the form of a software programme. With the guidance of the executive bodies that oversee regulatory accreditation, namely the MHRA, the HRA and the BSI, Oxford Heartbeat was able to resolve uncertainties surrounding the certification of innovative digital tools like PreSize®, and successfully pass regulatory audits.
On its journey to acquiring CE mark certification, Oxford Heartbeat was faced with the unique task of having to interpret and administer existing regulations to PreSize®, an innovative technology not envisaged by legal frameworks at the time of their writing.
“Input from regulatory bodies has been indispensable in ensuring that digital health innovators like us are able to fulfill our mission to benefit clinicians and their patients in the safest manner possible,” said Katarina Demeter, Regulatory Affairs Manager at Oxford Heartbeat. “With the rise of AI and advanced digital technologies, the definition of what qualifies as a medical device has never been broader. We are looking forward to seeing how the regulatory framework may grow to be more agile and inclusive in its application, in a manner that leaves as little to interpretation as possible.”
This CE mark was granted with reference to Oxford Heartbeat’s retrospective validation study, which was carried out in collaboration with four interventional neuroradiology centres in the UK. Based on a retrospective analysis of pre- and post-operative data from 65 brain stenting patients, PreSize® was able to successfully predict the final deployed stent configuration within the patients’ anatomies, with an excellent average accuracy of 96.75%. This is an unparalleled accuracy rate that significantly exceeds clinical expectations of 90%, a figure suggested by interventional neuroradiologists performing stenting surgeries. It also makes PreSize® one of the safest planning tools anywhere for clinicians performing stenting.
Having achieved this important milestone, Oxford Heartbeat will continue to pursue a transition to the MDR, in order to provide uninterrupted clinical support and engender unprecedented progress for minimally invasive neurovascular surgeries.
“We know that PreSize® is a timely innovation that will help prevent thousands of deaths in the years to come,” concludes Dr Katerina Spranger, Founder and CEO of Oxford Heartbeat. “Our aim, as always, will be to keep working until successful surgeries are the norm, not the exception.”
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