PIUR IMAGING, a global leader in tomographic 3D ultrasound technology, is proud to announce that its groundbreaking product, PIUR tUS Infinity, has received clearance from the U.S. Food and Drug Administration (FDA). This FDA approval marks a major milestone, allowing the company’s advanced ultrasound technology to be introduced to the U.S. healthcare market for the first time.
The PIUR tUS Infinity system is a revolutionary solution that transforms existing 2D ultrasound devices into advanced 3D imaging systems, providing an innovative and cost-effective tool for clinicians, particularly in thyroid imaging.
Empowering U.S. Clinicians with Advanced 3D Imaging Technology
The PIUR tUS Infinity is the world’s first standalone ultrasound enhancement system capable of upgrading nearly any 2D ultrasound device to capture comprehensive 3D images. 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.
“PIUR tUS Infinity is designed to meet the evolving needs of the U.S. healthcare system,” said Frederik Bender, CEO of PIUR IMAGING. “This technology offers an enhanced view into thyroid conditions, enabling clinicians to make more informed, precise decisions in patient care.”
The system offers multi-planar reconstructions from a single 2D sweep, enabling clinicians to assess thyroid conditions in three dimensions. 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).
A Game-Changer for U.S. Healthcare Workflows
At a time when the U.S. is facing a shortage of ultrasound specialists, PIUR tUS Infinity addresses this challenge by enabling physicians to review scans remotely, allowing for the integration of telehealth into diagnostic workflows. This asynchronous telehealth functionality enhances diagnostic efficiency and increases access to imaging services across the country.
“Our technology not only addresses the growing demand for imaging solutions in the U.S., but it also supports innovative workflows that enable remote care and flexible diagnostic solutions,” said Bender.
Revolutionizing Thyroid Imaging in the U.S. Market
With FDA clearance, PIUR tUS Infinity is set to transform thyroid imaging in healthcare facilities across the U.S. By upgrading existing ultrasound equipment to deliver 3D imaging, hospitals and clinics can elevate their diagnostic capabilities without the need for costly infrastructure upgrades. This scalable solution is ideal for healthcare providers looking to meet the increasing demand for advanced imaging while optimizing operational efficiency.
The system’s enhanced imaging capabilities may also qualify for reimbursement through CPT Category I code 76377, providing healthcare facilities with a clear pathway to improve patient outcomes while maximizing revenue potential.
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
