Piur Device Converting 2D Scans to 3D Cleared

FDA has cleared a Piur Imaging 510(k) for the Piur tUS Infinity, which the company says is an advanced ultrasound technology that changes existing 2D ultrasound devices into 3D systems for thyroid imaging. “This cutting-edge technology provides clinicians with highly detailed volumetric datasets of thyroid lobes and nodules in a single scan, significantly reducing operator dependency in ultrasound readings — a common limitation with traditional 2D ultrasound,” it says.

The device offers multi-planar reconstructions from a single 2D sweep that allows clinicians to assess thyroid conditions in three dimensions, according to Piur. “In addition, it 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 seamless data integration through PACS (Picture Archiving and Communication System),” the company says.