AliveCor’s bloodless hyperkalemia test scores the “Breakthrough Device” designation from the FDA

AliveCor KardiaMobile

The U.S. Food and Drug Administration (FDA) has AliveCor’s KardiaK Software Platform the rarely granted designation of “Breakthrough Device.” This means that the agency will consider the technology on an accelerated clearance track designed specifically for medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.

The KardiaK Platform screens for elevated levels of blood potassium (hyperkalemia) without requiring any blood from the patient. The technology employs a proprietary deep neural network trained to detect hyperkalemia using data from electrocardiograms (ECG) similar to those captured by AliveCor’s KardiaMobile and KardiaBand devices. AliveCor aims to use the platform to enable home-based hyperkalemia detection for patients with kidney disease, as well others at risk for this life-threatening condition.

“We are gratified that the artificial intelligence work we’re doing at AliveCor has been deemed so meaningful that it has achieved FDA Breakthrough Device status,” Vic Gundotra, CEO of AliveCor, said in a statement. “We view it as a key milestone in our corporate history and look forward to the further development of our non-invasive Hyperkalemia detection tools.”

Blood potassium is tightly regulated in the body and can cause life threatening cardiac arrhythmias and death when potassium levels increase even to mildly elevated levels. For the nearly 30 million US adults with chronic kidney disease, the one-day likelihood of death is nearly 3 times higher if a home potassium is 5.5 to 5.9 mmol/L, and over 13 times higher if it is 6.0 mmol/L or greater. For the 500,000 Americans with end stage kidney disease and on dialysis, hyperkalemia may contribute up to 40% of deaths.

Although treatments for hyperkalemia are effective and readily available, diagnosis of hyperkalemia, particularly outside of the hospital, can be a challenge as symptoms may be vague or absent. AliveCor aims to enable patients with kidney disease to record an ECG and use KardiaK at home. Noninvasive and convenient, the bloodless KardiaK platform has the potential to revolutionize the standard for diagnosis of hyperkalemia.