FDA designates bloodless AI test a 'breakthrough device'

The FDA recently designated AliveCor's bloodless test for hyperkalemia a "breakthrough device," placing the platform on a track for accelerated regulatory clearance.

The FDA awards breakthrough device status to medical devices that demonstrate the potential to address unmet medical needs for life-threatening or severely debilitating conditions, according to electrocardiogram gadget developer AliveCor.

AliveCor says its test, dubbed KardiaK Software Platform, can detect hyperkalemia without requiring a blood draw. Hyperkalemia describes a life-threatening condition in which the potassium level in a patient's blood is higher than normal, which can lead to cardiac arrest.

The KardiaK Software Platform uses deep neural networks — a type of artificial intelligence — to screen data from ECGs for elevated levels of blood potassium.

If greenlit by the FDA, the test would enable patients at risk for hyperkalemia, such as those with kidney disease, to screen for the condition at home, rather than being required to visit a laboratory for a blood test.

"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," Paul Friedman, MD, chair of the cardiovascular medicine department at Rochester, Minn.-based Mayo Clinic and member of the team that co-developed the test, said in a news release.

AliveCor, which develops personal ECG technologies that apply AI to improve traditional heart rhythm analysis, has had success receiving FDA approval for its devices. The company received FDA clearance for its EKG Apple Watch accessory in November 2017.

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