FDA awards breakthrough designation to AI-powered TB diagnostic tool

Despite a decline for almost 30 years, tuberculosis (TB) cases have increased recently, with 8,300 patients in the U.S. testing positive for the disease in 2022, according to CDC data. Artificial intelligence (AI) aims to turn the tide, with a new application earning breakthrough designation from the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health.