Skip to content
AccurKardia's AK+ Guard
Wara Samar

23rd January 2025

AccurKardia Earns FDA Breakthrough Device Designation for AK+ Guard™ 

AccurKardia, a pioneer in ECG-based diagnostics technology, has announced a major milestone: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its AK+ Guard™ hyperkalemia detection software. This investigational technology leverages Lead I ECG data to detect moderate to severe hyperkalemia (excess potassium in the blood) and alert patients and clinicians, potentially preventing life-threatening cardiac events. 

AK+ Guard™ is designed to integrate with a variety of FDA-cleared consumer and clinical wearables, such as smartwatches, that already capture Lead I ECG data. This innovation enables hyperkalemia monitoring outside of clinical settings, offering earlier detection and intervention opportunities for high-risk populations. The device is particularly beneficial for patients with chronic kidney disease (CKD), end-stage renal disease, and other risk factors. 

In the U.S., 37 million people suffer from CKD, and over half a million patients undergo dialysis annually. Among CKD patients, hyperkalemia increases the risk of all-cause mortality by 16.6%, and for dialysis patients, this risk rises to 33% after a severe episode. The scale of the problem underscores the need for such innovation.

Accelerating Pathways with the FDA TAP Program 

In addition to the Breakthrough Device Designation, AK+ Guard™ has been accepted into the FDA Total Product Life Cycle Advisory Program (TAP). This program facilitates earlier and more frequent engagement with the FDA, expediting regulatory approvals and improving device evaluation quality. AccurKardia’s participation in TAP represents a significant step toward rapid commercialization of AK+ Guard™. 

The FDA’s support marks another milestone in AccurKardia’s mission to improve patient outcomes and save lives. The company believes the current standard of care for hyperkalemia detection underserves patients. AK+ Guard aims to provide a faster, more accessible pathway to detection and management.

Broadening the Scope of ECG Diagnostics 

AccurKardia’s progress with AK+ Guard builds on its previous achievement: FDA Breakthrough Device Designation for its Aortic Valve Stenosis (AVS) screening software, AK-AVS™. This tool analyzes existing ECG data within electronic health records to identify potential cases of aortic valve stenosis, helping prioritize patients for echocardiograms. These advancements reflect the company’s broader vision of transforming ECG data into a comprehensive diagnostic tool and biomarker. 

About AccurKardia 

AccurKardia is a leading developer of ECG diagnostics software, dedicated to enhancing patient outcomes through innovative technologies. The company’s cloud-based tools, including the FDA-cleared AccurECG™ and investigational AK-AVS™ software, leverage the ubiquity of ECG to address critical diagnostic gaps. As a participant in the 2024 MedTech Innovator cohort and the American Heart Association’s Heart and Brain Health Accelerator track, AccurKardia is at the forefront of advancing medical diagnostics globally. 

Countdown to MedTech World Dubai 

Time is running out—MedTech World Dubai is fast approaching! This MedTech event brings together global healthcare innovators and industry leaders for an experience you won’t want to miss. Whether you aim to grow your network, explore pioneering technologies, or foster meaningful collaborations, this is your chance. Act now to secure your spot and grab your ticket before prices increase!

MedTech Dubai 2025