Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor for regulatory approval to the FDA and CE-marking in 2024. Continue reading