(London, UK) 10 September 2024. Following our recent announcement that hepatoSIGHT has received MHRA UKCA marking, we are excited to share that hepatoSIGHT has now also achieved CE marking from the European Medicines Agency (EMA). This significant milestone allows us to extend the availability of the pioneering liver disease case-finding tool to millions more people across Europe, with the potential to transform the early detection of liver disease on a much larger scale.
CE marking is a crucial regulatory approval, signifying that hepatoSIGHT meets the EU’s stringent health, safety, and environmental protection standards. This clearance means the tool can now be deployed in clinical settings across EU member states, significantly expanding its reach. Given that liver disease is a growing public health crisis globally, the ability to scale hepatoSIGHT to a continental level is an essential step forward in tackling this silent epidemic.
Liver disease often progresses without symptoms until it is too late for effective intervention, which is why early detection is critical. hepatoSIGHT helps clinicians to stratify populations at risk of developing chronic liver disease by scanning decades of historical medical data, including blood records. By identifying those who may be at risk earlier in their disease pathway, the tool provides healthcare professionals with the information needed to intervene before the disease advances to more severe stages, such as liver cancer or cirrhosis.
An estimated 29 million people in Europe suffer from a chronic liver condition1, many of whom are undiagnosed due to the asymptomatic nature of the disease in its early stages. Liver cancer has the fastest-growing incidence rate of all cancers in Europe, and it is one of the leading causes of cancer-related deaths.
One of the biggest challenges in fighting liver disease remains its late diagnosis. In most cases, people only become aware of their condition when it has reached an advanced stage, at which point treatment options are limited and outcomes are often poor. hepatoSIGHT helps clinicians address this challenge head-on by identifying people who are at risk, potentially before symptoms appear, giving them a better chance for successful treatment and improved quality of life.
“This is a tremendous achievement for our team, and it comes at a time when early detection has never been more critical,” says Dr Tim Jobson, consultant NHS gastroenterologist and co-founder of Predictive Health Intelligence. “Our goal has always been to end the late diagnosis of liver disease, and CE marking enables us to scale hepatoSIGHT’s reach to millions of people across Europe who are living with undiagnosed liver conditions.”
With both UK and EU regulatory clearances now in place, hepatoSIGHT is set to play an increased role in helping clinicians across Europe identify and treat liver disease before it’s too late. Predictive Health Intelligence is already in discussions with healthcare providers across multiple EU countries to integrate the tool into their clinical workflows, with the potential to improve outcomes for millions of patients.
To learn more about hepatoSIGHT and what these recent regulatory clearances mean, please visit our MHRA press release here:https://predictivehealthintelligence.co.uk/news/case-finding-tool-for-liver-disease-hepatosight-receives-mhra-clearance/
About Predictive Health Intelligence
Industry Media Contact
James Hounsell
Co-Founder, Evolene
James.Hounsell@evolene.co.uk