Positive news30 Aug 2025 07:21
At Loop Diagnostics we celebrate a great milestone: our SeptiLoop® test has obtained the CE Marking according to the IVDR Regulation (Class C), the most demanding regulation in Europe for in vitro diagnostics. With this certification, SeptiLoop® becomes one of the first innovative devices registered and approved under this regulatory framework in Europe.
🔬 SeptiLoop® is the first functional immunological test capable of identifying bacteremia-induced immunosuppression in the early stages of sepsis, offering results in less than 3 hours, with a simple implementation and without the need for complex equipment.
💡 This achievement opens the door to hospital commercialization in Europe, with agreements already underway in Spain, the United Kingdom and Italy.
📈 To promote this expansion, we have opened a €5 million financing round.