AliveCor snags FDA breakthrough device status for bloodless hyperkalemia test

Dive Brief:

AliveCor is the latest company to obtain a breakthrough device designation from the FDA, the company announced Monday. Its KardiaK Software Platform, which aims to screen for elevated blood potassium levels without needing patient blood, will receive expedited review from the agency.
The company says that the technology could enable patients with kidney disease and others to detect hyperkalemia from home, instead of in a hospital setting.
The device, which still must gain FDA clearance, utilizes artificial intelligence to detect elevated blood potassium levels by crunching data from an electrocardiogram (EKG).

Dive Insight:

Left untreated, hyperkalemia can result in life-threatening heart rhythm problems, including death. Although potassium binder drugs such as patiromer and zirconium cyclosilicate are effective, diagnosis of the condition remains tricky, according to AliveCor.

Currently, a blood test is needed to measure blood potassium levels, requiring a visit to a care setting and laboratory work. AliveCor hopes that its KardiaK platform can move that process to patients’ homes. Vic Gundotra, CEO of AliveCor, called the FDA designation a “key milestone” for the company, in a statement.

AliveCor has been active in developing EKG monitoring tools: last November, FDA cleared its KardiaBand application for use with Apple Watch. At the American College of Cardiology annual meeting this year, AliveCor presented research that suggested that the app could detect hyperkalemia.

“This test, which performed extremely well in our evaluation using millions of ECGs, holds the promise of enabling people to painlessly determine whether a life-threatening and otherwise silent and very treatable condition is present — from the comfort of their own homes and within seconds,” said Paul Friedman, chair of the Mayo Clinic Department of Cardiovascular Medicine and a member of the team that co-developed the test.

FDA’s breakthrough device designation, established as part of the 21st Century Cures Act, enables the agency to fast track review of devices that demonstrate potential to help treat unmet medical needs for life threatening diseases. A FDA spokesperson told MedTech Dive that the agency has granted the breakthrough device designation to 83 devices as of the end of July.