AlgoDx, which focuses on supporting disease prediction with machine learning algorithms, has announced the obtention of regulatory approval from the Swedish Medical Products Agency (MPA) to start a sepsis prediction study at an Intensive Care Unit (ICU) in Sweden.
The study has previously been approved by the National Ethics Committee through an expedited review for research that has potential to provide benefit for the treatment and prevention of Covid-19, given that sepsis is a common complication in connection with Covid-19.
“We have had a very constructive dialogue with the MPA and been able to justify the design of our clinical study that will include a vulnerable population consisting of intensive care patients, where our sepsis prediction software addresses an unmet medical need. This study is the largest randomized clinical trial with a sepsis prediction algorithm ever conducted and is designed to clinically validate our product. We hope to be able to demonstrate that our technology can improve patient outcomes at ICUs,” says David Becedas, Director Clinical Research, AlgoDx.
Photo of David Becedas. Photographer: Keyvan Bamdej