Medical imaging AI company Qure.ai has secured breakthrough device designation from the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) for its tuberculosis software, qSpot-TB.
qSpot-TB is a second-read computer aided detection (CAD) and diagnosis device that analyses chest x-rays, identifying all radiological signs suggestive of tuberculosis, according to the firm.
The company has also recently secured FDA clearances for its qXR-LN software, which identifies and localizes lung nodules; its qXR-CTR software, which measures cardiothoracic ratio value; its qXR-PTX-PE software for triage of pneumothorax and pleural effusion in emergency rooms and intensive care units; and its qER software for head CT scans, it said.
