AI-powered kidney disease diagnostic tool receives FDA 'Breakthrough Device' designation

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The first artificial intelligence-enabled device for diagnosing and managing fast-progressing kidney disease has been granted "Breakthrough Device" designation from the FDA, Cardiff, U.K.-based clinical technology company Renalytix AI announced on May 2.

The KidneyIntelX uses machine learning algorithms to analyze predictive blood-based biomarkers and information from a patient's EHR to detect kidney disease, then provide information to improve the clinical management of the disease. The device specifically caters to patients with Type 2 diabetes, who have an elevated risk of developing kidney disease.

"Breakthrough Device" status does not guarantee FDA approval, but it does acknowledge a medical device's potential in the diagnosis or treatment of debilitating and life-threatening diseases. Devices with this designation are expedited through the FDA's assessment and review process in an effort to give patients and healthcare providers access to them as soon as possible.

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