Alivecor Inc. has secured CE marking for its Kardia 12L electrocardiogram (ECG) system, which is powered by its KAI 12L AI technology and can detect life-threatening cardiac conditions. Kardia 12L is a portable, AI-guided, 12-lead ECG solution that delivers measurements and interpretations similar to standard 12-lead ECG solutions, right at the point of care. The company said the simplified design will enable faster acquisition of complete ECG data while leading to better patient outcomes.
Roche Holdings AG reported results from its TSIX study which demonstrated that its sixth-generation Troponin T test is accurate at diagnosing heart attacks not only in men but also women. Recently granted CE mark, the Elecsys Troponin T hs Gen 6 test, demonstrated it was able to identify acute myocardial infarction (AMI) and identify those not having an AMI, with a high level of precision, ensuring that patients receive the care they need at the earliest opportunity.
Researchers from the University of Edinburgh seek protection for an algorithm developed using artificial intelligence that could be used by doctors to diagnose heart attacks more quickly and effectively.
OSE Immunotherapeutics SA disclosed a $713 million deal with Abbvie Inc. for preclinical-stage monoclonal antibody OSE-230, a potentially first-in-class therapy for treating a range of inflammatory diseases, while Idorsia Ltd. found a partner for two phase III-stage assets in Viatris Inc., as dealmaking continues strong in 2024.
Shineco Inc.’s subsidiary Changzhou Biowin Pharma received marketing approval from China’s NMPA for its test device that can complete a diagnosis of acute myocardial infarction in five minutes. The five-minute cardiac test relies on a combination of three major cardiac markers that can detect cardiac troponin I, myoglobin and heart fatty acid binding protein in a single test.
Factor XIa inhibitors milvexian and asundexian, hailed as the next-generation class of anticoagulants, earned mixed reviews on phase II data presented during the European Society of Cardiology Congress 2022. However, developers Bristol Myers Squibb Co./Janssen Pharmaceutical Co. and Bayer AG, respectively, are moving into late-stage testing, citing clear mechanisms of action that put the FXIa drugs at least on par with approved factor Xa drugs in terms of efficacy while offering potentially better safety profiles that could give physicians an option for patients with stroke or atrial fibrillation who are currently undertreated with anticoagulants due to bleeding risks.
PARIS – Miracor Medical SA secured a $28 million series E funding round for its Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) impulse system, intended for treating patients presenting with ST-Elevation Myocardial Infarction (STEMI). “This funding will be used to move the PiCSO clinical trial program forward, and to begin distributing our technology in Europe,” Olivier Delporte, CEO of Miracor, told BioWorld.
Zoll Medical Corp., of Chelmsford, Mass., received CE mark approval to market its second-generation Supersaturated Oxygen (SSO2) Therapy in Europe and other countries that accept CE mark. The therapy, which delivers hyperbaric levels of oxygen to the ischemic heart muscle immediately following percutaneous coronary intervention, has been shown to significantly reduce damage to the heart muscle after an acute myocardial infarction.
