• Having received a CE mark (Class I Measuring, MDD) in March 2020 from the British Standards Institution (BSI), Oxford Heartbeat’s medical software, PreSize® Neurovascular, is now deemed ready for market release at all hospitals across the EU and UK
• The CE mark award is a huge milestone for Oxford Heartbeat as clinicians around Europe and the UK performing high-risk brain surgeries will now have access to PreSize®, enabling thousands of patients every year to have safer surgeries
• With the full ISO13485:2016 certification for its management system and processes, in addition to CE, Oxford Heartbeat will continue to develop its medical software in compliance with the highest health, safety and environmental protection standards recognised within the European Economic Area (EEA)
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.”
Note to Editors:
About Oxford Heartbeat
Oxford Heartbeat’s vision is a world where every patient and doctor is supported by the most advanced technologies, and successful surgical outcomes are the norm, not the exception. We are transforming this vision into reality by providing clinicians with the cutting-edge technology they need to make life-saving decisions in preparing and executing high-risk surgeries. We strive to be innovative, rigorous, transparent and caring, putting clinicians and patients at the heart of everything we do.
About PreSize® Neurovascular
PreSize® Neurovascular helps interventional neuroradiologists (INRs) to prepare for minimally invasive brain stenting procedures. High levels of risk and inadequate technologies currently used in these surgeries mean that stents are fitted in the patients’ anatomies based on a large amount of guesswork. PreSize® was designed to rectify these problems and help clinicians better prepare and execute surgeries in a more accurate way. INRs import patient scans into PreSize® and position the stent into the reconstructed virtual blood vessel model. PreSize® allows INRs to explore different stent sizes/makes in a safe virtual setting, making adjustments to their satisfaction before operating. Thus the best-fit stent is selected, reducing surgical complications and improving patient outcomes.