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<\/a>\nAI-powered AK+ Guard hyperkalemia detection software uses Lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia. Designed to work with a range of consumer and clinical wearables, including smartwatches, hyperkalemia monitoring can occur outside of the clinic, prompting earlier intervention to prevent exacerbations or sudden cardiac events. Additionally, by helping to manage hyperkalemia risk, AK+ Guard could facilitate maintenance of cardiorenal protective therapies in at-risk chronic kidney disease and heart failure patients.<\/p>
\nAK+ Guard uses advanced deep learning to transform a standard Lead I ECG into a non-invasive metabolic biosensor, with the AI analyzing the waveform for signs of hyperkalemia. AK+ Guard\u2019s AI has been trained on a vast dataset of paired ECG and blood-serum values to correlate often subtle electrical signatures with hyperkalemia. This model received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and was accepted in the FDA TAP program in January 2025.<\/p>
\nA recent independent validation study, conducted across the Sharp HealthCare system, tested AK+ Guard\u2019s ability to detect moderate-to-severe hyperkalemia (\u22656.5 mmol\/L) using Lead I ECGs. The model achieved an AUROC of 0.903, with 82.3% sensitivity and 82.5% specificity in results presented at 2025 American Heart Association Scientific Sessions.<\/p>
\n\u201cWe saw that the current standard of care for hyperkalemia detection and monitoring had been underserving patients. Our solution delivers a speedier, more accessible pathway to detection and risk management, making a meaningful impact on patient care,\u201d said Moin Hussaini<\/a>, chief product officer of AccurKardia. \u201cAK+ Guard detects hyperkalemia in the ECG when it begins to pose a cardiac risk, and enables monitoring between lab visits. We\u2019re also proud that our AI delivers equitable, high-performance diagnostics across diverse populations, a critical differentiator in medical AI.\u201d<\/p> \nNow celebrating its 10th anniversary, the MedTech Breakthrough Awards program has spent a decade recognizing the companies driving meaningful progress and improving patient care across the global health and medical technology industry. The program spans a wide range of categories \u2013 including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices and beyond \u2013 honoring the innovations reshaping how care is delivered worldwide.<\/p> \nThis year's program drew a record-breaking number of nominations from leading companies and startups across more than 20 countries, reflecting the growing global impact and momentum of the digital healthcare industry.<\/p> \n\u201cAccurKardia\u2019s AK+ Guard represents a fundamental leap forward in patient care,\u201d said Steve Johansson<\/a>, managing director, MedTech Breakthrough. \u201cBy replacing a blood draw with an AI-processed signal, AK+ Guard empowers patients to monitor themselves at home or anywhere, non-invasively and frequently. AccurKardia has not just automated a manual task; they are enabling a life-saving physiological measurement that was previously impossible to obtain outside of a laboratory.\u201d<\/p> \nAbout AccurKardia<\/b><\/p> \nAccurKardia is an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives globally. With initial applications in cardiology, the company offers transformative, cloud-based diagnostic tools, including AccurECG\u2122 2.0, an FDA-cleared Class II software as a medical device (SaMD) for fully automated, near real-time ECG interpretation. AccurKardia is also advancing an investigational pipeline of ECG-based biomarkers, including AK+ Guard\u2122 for hyperkalemia risk assessment using Lead I ECG, and AK-AVS\u2122 for aortic stenosis risk assessment, both of which have received FDA Breakthrough Device Designation. For more information, please visit www.accurkardia.com<\/a>.<\/p> \nAbout MedTech Breakthrough<\/b><\/p> \nPart of Tech Breakthrough<\/a>, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information visit MedTechBreakthrough.com<\/a>.<\/p> \nTech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose.<\/p> \nDisclaimer:<\/b><\/p> \nFor detailed technical AccurECG 2.0 requirements, relevant disclosures, and approved indications for use, please refer to the U.S. FDA 510(k) K252361 summary and product labeling.<\/p> \nAK-AVS and AK+ Guard are currently for research use only and have not been cleared or approved by the U.S. FDA for use in the United States. This technology is under development and intended solely for investigational purposes.<\/p>