MOUNTAIN VIEW, Calif. – The U.S. Food and Drug Administration has granted Breakthrough Device designation to AliveCor’s artificial intelligence-powered KardiaK software platform.
The designation means that the FDA 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.
“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,” said Vic Gundotra, CEO of AliveCor, 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.”
The KardiaK Platform screens for hyperkalemia—elevated levels of blood potassium—without requiring blood from the patient. The technology uses a proprietary deep neural network trained to detect hyperkalemia using data from electrocardiograms.
AliveCor aims to use the platform to enable home-based hyperkalemia detection for 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,” Gundotra said.