PIUR IMAGING, a leader in tomographic 3D ultrasound innovation, announces FDA clearance for PIUR tUS inside, integrated with select GE HealthCare LOGIQ™ ultrasound systems. This clearance enables U.S. healthcare providers to transform imaging workflows and access advanced AI-supported 3D imaging capabilities.
PIUR tUS inside: Transforming 2D Ultrasound into 3D Imaging
PIUR tUS inside utilizes novel proprietary sensor technology to provide diagnostic tomographic 3D imaging with select GE LOGIQ™ devices, enabling radiology and telehealth workflows for ultrasound. Clinicians simply attach the compact PIUR Sensor during 3D scans and remove it for routine 2D use.
“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, General Manager of PIUR IMAGING Inc.
This system enables comprehensive 3D volume acquisitions that go far beyond the limitations of traditional single slice 2D scans. The system combines these scans with computer-assisted tools for detailed review, telehealth collaboration, and improved patient care
Enhancing Diagnostic Confidence and Workflow Efficiency
- Comprehensive 3D visualization: Automatically reconstructs sagittal, transverse and coronal views from a single sweep
- Semi-automatic thyroid analysis: AI-supported 3D image segmentation measures nodules and lobes and generates PACS-ready reports
- Up to 80% less operator variability: Automated volume and nodule assessment significantly improves consistency across users
- Streamlined reporting and digital storage: Automated thyroid reports and PACS integration save time and reduce manual documentation effort
A Scalable Solution for a Strained Workforce
As the U.S. healthcare system faces increasing demand for imaging services and a shortage of trained specialists, PIUR tUS inside offers a practical and forward-looking solution. Sonographers can perform the scan while physicians review from any location, enabling efficient telehealth workflows and more flexible, distributed care models.
Established Reimbursement Pathway for 3D Imaging with PIUR tUS inside
With FDA clearance, PIUR tUS inside not only enhances diagnostic capabilities—it also aligns with existing U.S. reimbursement frameworks. An established CPT I reimbursement code offers healthcare providers a clear path to adopt cutting-edge 3D imaging while maintaining financial sustainability.
About PIUR IMAGING
PIUR IMAGING is an ISO 13485-certified and FDA-cleared MedTech company with offices in Austria, Germany, and the United States. The company develops AI-powered 3D ultrasound solutions designed to enhance everyday clinical workflows and enable scalable, reproducible, and efficient diagnostic imaging.
Media Contact
Melanie Krauss
Head of Marketing
PIUR IMAGING GmbH
pr@piurimaging.com
