FDA Clears Emerging 3D Ultrasound Technology

Emphasizing proprietary sensor technology to provide tomographic 3D ultrasound imaging, the PIUR tUS inside modality has garnered 510(k) clearance from the Food and Drug Administration (FDA).

The PIUR tUS inside , which will be available with select GE HealthCare Logiq ultrasound systems, offers a combination of enhanced imaging, automated reporting and artificial intelligence (AI)-enabled segmentation, according to PIUR Imaging, the developer of PIUR tUS inside.

The company noted that key attributes of PIUR tUS inside include:

• automated 3D reconstruction of sagittal, transverse and coronal views from one sweep;

• automated volume and nodule assessment;

• AI-powered 3D segmentation with nodule and lobe measurements; and

• a combination of automated thyroid reporting and PACS integration for streamlined documentation.

“With the combination of this integrated solution and our previously FDA cleared Infinity system, PIUR IMAGING will continue to strengthen the role of enhanced 3D ultrasound imaging to improve patient outcomes in the U.S.,” said Tullio Giannitti, the general manager of PIUR Imaging.