Accurkardia

AccurKardia is an ECG-led diagnostics software company transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives globally. Its cloud-based platform includes AccurECG™, an FDA-cleared Class II software as a medical device (SaMD) that delivers fully automated, near real-time ECG interpretation and integrates seamlessly into existing clinical workflows. AccurECG™ was named “Best New ECG Technology” at the 2025 MedTech Breakthrough Awards. AccurKardia’s pipeline includes AK+ Guard™—an AI-driven hyperkalemia detection solution using Lead I ECG data to help identify life-threatening high potassium levels earlier in patients with CKD and ESRD—which received FDA Breakthrough Device Designation and acceptance into FDA’s Total Product Life Cycle (TAP) program in December 2024; and AK-AVS™, an AI model for aortic stenosis detection via 12-lead ECGs, which received FDA Breakthrough Device Designation in October 2024. AccurKardia completed the 2024 MedTech Innovator (MTI) cohort and was one of five companies selected for the American Heart Association’s inaugural Heart & Brain Health Accelerator track within MTI. AccurKardia also completed Cohort 3 of Mayo Clinic Platform_Accelerate in 2023.(AK+ Guard™ and AK-AVS™ are investigational and not commercially available.)