Vienna, Austria-based Piur Imaging has received clearance from the U.S. Food and Drug Administration (FDA) for its tUS Infinity tomographic 3D ultrasound system.
The Piur tUS Infinity is a standalone ultrasound enhancement system capable of upgrading 2D ultrasound devices to capture comprehensive 3D images, the company said. The technology is designed to provide clinicians with detailed volumetric datasets of thyroid lobes and nodules in a single scan. The device supports risk assessment of nodules based on the American College of Radiology's Thyroid Imaging Reporting and Data System (ACR-TIRADS) and generates standardized reports for data integration through PACS, Piur said.
In addition, the system enables physicians to review scans remotely, which allows it to be integrated into diagnostic telehealth workflows, the company said.
