PIUR IMAGING Receives FDA Clearance for PIUR tUS inside

Bringing Advanced 3D Ultrasound to U.S. Healthcare

PIUR tUS inside FDA-cleared

(Vienna, Austria 07/02/2025) – 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.

To schedule a demo or learn more, visit Contact | Piur Imaging

About PIUR IMAGING

Headquartered in Vienna with offices in Munich and Cambridge (MA), PIUR IMAGING is an ISO-13485 certified and FDA-cleared medical device company, specializing in advanced tomographic 3D ultrasound solutions. Our mission is to improve diagnostic workflows and enhance patient care by offering innovative add-on solutions for existing ultrasound devices, empowering clinicians with accurate, reproducible imaging for optimal patient outcomes.