The United States Food and Drug Administration has granted Breakthrough Device Designation to a medical device that is designed to screen for hyperkalaemia (high blood potassium levels) without taking a blood sample. For more detailed information about this, you can read the source press release here, at PR Newswire.
Hyperkalaemia is a serious but often effectively treatable condition caused by high levels of potassium in the blood. Potassium is an important nutrient for the body, but if blood potassium levels become too high it can be dangerous. According to the source article, hyperkalaemia may contribute to as many as 40% of deaths from end-stage kidney disease, and high levels of potassium are associated with an increased risk of death. Hyperkalaemia is typically associated with few, or non-specific symptoms such as muscle weakness and nausea, and, at the moment, it is often diagnosed through a blood test taken at a lab. This combination of features means that doctors may be slow to diagnose hyperkalaemia.
To address this issue in diagnosing hyperkalaemia, AliveCor is developing the KardiaK Software Platform. This is a device that may have the potential to detect hyperkalaemia without the need for patients to have invasive blood tests or travel to a lab. KardiaK is designed to screen for high levels of blood potassium using a proprietary deep neural network that can use data from electrocardiograms to identify hyperkalaemia. AliveCor says that this device may allow people to test for hyperkalaemia in their own homes. Dr Friedman, who helped to develop the test, says, “It may save people’s lives, and save the health care system dollars.”
The KardiaK software has recently been granted Breakthrough Device Designation by the FDA.
Breakthrough Device Designation
Breakthrough Device Designation is designed to help patients access important medical devices more quickly. It is granted by the FDA to medical devices that may have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.