First AI blood test obtains European Medical Device Regulation certification

With the receipt of the European Medical Device Regulation for its AI blood test interpretation software, Smart Blood Analytics Swiss has become one of the ten medtech companies with this certification. 

Blood tests are vital for identifying, diagnosing, and treating diseases. As healthcare shifts towards early intervention, the prompt and precise analysis of blood test outcomes is critical for future patient care quality and cost management. Interpreting results becomes challenging when multiple parameters deviate from normal or even when all values are within the normal range. Established in 2016 in Switzerland with offices in Slovenia, Smart Blood Analytics Swiss SA is a pioneering leader in healthcare technology in the segment of blood test result interpretation.

Their flagship product, SBAS Software, employs artificial intelligence to revolutionize the interpretation of blood test results, predicting the most probable diagnoses based solely on an individual’s blood test results. The models can predict hundreds of groups of diseases and medical conditions in the field of internal medicine. The solution not only enhances the speed and accuracy of the interpretation of blood test results but also empowers healthcare professionals with valuable insights into patient health. By streamlining the diagnostic process, SBAS Software contributes to faster and more accurate medical decisions, ultimately improving patient outcomes.

SBAS Software has achieved the first European Medical Device Regulation (EU-MDR) certification, recognising it as a medical device using cutting-edge AI technology for blood test result interpretation. The EU-MDR certification process is a rigorous and comprehensive assessment of medical device safety, quality, and compliance with European Union medical device requirements. This achievement marks a significant milestone, positioning Smart Blood Analytics Swiss among only 10 AI medical device companies recognized with the EU-MDR certification to date, based on the European Database of Medical Devices.

"Receiving EU-MDR certification is a testament to our dedication to innovation and patient well-being. We are immensely proud of our SBAS Software and the transformative impact it has on the field of healthcare. This certification is a recognition of our commitment to delivering the highest quality solutions to healthcare professionals and, ultimately, to patients worldwide," said Marko Notar, CEO and Founder of Smart Blood Analytics Swiss.

Alongside Notar, who lives in Zurich, Swiss Blood Analytics has a team of six employees, the majority of whom are based in Slovenia. One of its Investors, Ivan Pusik is also residing in Zurich.

(Press release/RAN)