FDA Clears Enhanced 3D Ultrasound Platform for Thyroid Imaging

Offering an ultrasound platform that may have the capability to upgrade two-dimensional (2D) ultrasound devices with access to three-dimensional (3D) views of thyroid conditions, the Piur tUS Infinity system has garnered 510(k) clearance from the Food and Drug Administration (FDA).

The Piur tUS Infinity platform enables clinicians to obtain multiplanar reconstructions from a single sweep with a traditional 2D ultrasound device, according to Piur Imaging, the developer of Piur tUS Infinity.

Providing detailed volumetric assessment of thyroid lobes and nodules with a single scan, Piur Imaging said the Piur tUS Infinity platform facilitates nodule classification with the Thyroid Imaging Reporting and Data System (TI-RADS). The company added that the Piur tUS Infinity platform facilitates standardized reporting for PACS systems, and use of the 3D system may be reimbursed via CPT Category I code 76377.

“This technology offers an enhanced view into thyroid conditions, enabling clinicians to make more informed, precise decisions in patient care,” noted Frederik Bender, the chief executive officer of Piur Imaging.