PIUR tUS Infinity
by PIUR Imaging
· Based in Austria →
— AI Software Solution That Streamlines Ultrasound Examinations
Contact for pricing
Regulatory Status Disclosed
Overview
PIUR tUS Infinity is an AI-powered tomographic ultrasound solution designed to upgrade existing 2D ultrasound devices with advanced 3D imaging capabilities. It is vendor-agnostic, allowing integration with various standard ultrasound systems. The system utilizes an IMU sensor to track probe movement during a freehand scan, generating high-resolution 3D volumetric datasets. This technology aims to streamline ultrasound examinations by providing faster scans, more consistent results, and automated reporting, particularly for thyroid imaging. It supports medical professionals in the diagnostic workflow of thyroid and thyroid nodules, offering features like AI-assisted analysis, annotation, and classification using the ACR-TIRADS calculator. The system also facilitates automated report generation and seamless integration with PACS, significantly reducing scan-to-report times and operator dependency.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Vendor-agnostic AI upgrade for existing 2D ultrasound devices
- Tomographic 3D ultrasound imaging from 2D data
- AI-powered analysis and annotation of thyroid lobes and nodules
- Automated report generation (PACS-ready DICOM SR)
- Integrated ACR-TIRADS calculator for nodule classification
- Reduced scan-to-report time (up to 60% faster)
- Reduced operator dependency and variability in ultrasound readings
- Wireless IMU sensor for precise probe movement tracking
- Multiplanar reconstructions and 3D volume renderings
- DICOM Worklist integration
Use Cases
- Thyroid imaging and nodule analysis
- Vascular imaging (e.g., arteriovenous fistulas, carotid disease)
- Nerve imaging
- Post-ablation monitoring of thyroid nodules
- Improving diagnostic quality in ultrasound
- Optimizing clinical workflow efficiency
What Physicians Need to Know
Key Capabilities
Transforms existing 2D ultrasound devices into advanced 3D tomographic imaging systems, providing high-resolution volumetric datasets of structures like thyroid lobes and nodules. It features AI-powered analysis, automated annotation, and reporting, significantly reducing operator dependency and variability. The system supports nodule classification with an integrated ACR-TIRADS calculator. While primarily focused on thyroid imaging, it also supports vascular and nerve imaging in some regions, with plans for broader application expansion.
Clinical Utility
Aids in the diagnosis of thyroid diseases and nodules by offering detailed 3D information, comparable to CT or MRI, which can improve diagnostic quality and precision. It streamlines workflows, reducing scan-to-report time by up to 60% and enabling standardized reporting for PACS systems. This efficiency can lead to increased patient throughput and potentially reduce the need for more invasive or costly imaging modalities like CTA/MRA.
Integration Options
Designed as a vendor-agnostic add-on, PIUR tUS Infinity can upgrade most existing 2D ultrasound devices that have a digital video output. The system comprises an Infinity Video Box (for image transfer via Wi-Fi), a PIUR Sensor (for probe tracking via Bluetooth), and software running on a standard Windows computer. It generates structured DICOM SR reports for seamless integration and archiving with PACS. A PowerScribe plug-in is also planned for future release.
Compliance Status
The PIUR tUS Infinity system is FDA 510(k) cleared (K240036) for thyroid imaging in the U.S. It is also a Class IIa medical device in accordance with the Medical Device Regulation 2017/745 (MDR) in Europe, indicating CE Mark conformity. The company is ISO 13485 certified and the system complies with DICOM standards (NEMA PS 3.1-3.20).
Pricing Model
Specific pricing information is not publicly disclosed and requires direct contact with PIUR Imaging. However, the use of the 3D system may be eligible for reimbursement via CPT Category I code 76377 in the United States, supporting economic optimization for thyroid ultrasound procedures.
User Experience
Features a remade, intuitive user interface designed for ease-of-use and a streamlined diagnostic workflow with fewer clicks. The platform guides clinicians through a three-step process: sweep acquisition and AI analysis, review and verification of results, and automated report generation. Users are required to be physicians skilled in ultrasonic diagnosis with knowledge of human anatomy and practical ultrasound experience.
Support Quality
PIUR Imaging provides comprehensive onboarding, webinars, and user manuals. Training is included with implementation, and a dedicated support team is available for assistance with integration, troubleshooting, and clinical questions.
Implementation Complexity
Considered a standalone enhancement system, it requires a compatible 2D ultrasound device with a digital video output. The system components include the Infinity Video Box, Infinity Sensor (clips onto the transducer), and a workstation (computer) meeting specific hardware requirements (e.g., Windows 10 64-bit, Nvidia Graphics Card, Intel i7/i5 processor, 8GB RAM). Official training by an authorized person is a prerequisite for use.
Evidence Base
Performance validation testing and software verification/validation testing have been conducted, demonstrating accurate representation of key processing parameters and non-inferiority of volume measurements. Clinical trials are ongoing to further compare its effectiveness and consistency in measuring thyroid nodule volume against traditional 2D ultrasound, with initial research indicating promise for improved accuracy. Early clinical adopters have reported significant workflow acceleration and improved standardization of thyroid assessments.
Physician Tip
Leverage PIUR tUS Infinity's 3D volumetric data for a more comprehensive assessment of thyroid nodules, especially for monitoring growth over time, as it reduces inter- and intra-observer variability compared to 2D ultrasound. Utilize the AI-assisted annotation and integrated ACR-TIRADS calculator for standardized reporting and efficient risk assessment. The significant reduction in scan-to-report time can optimize your clinic's workflow and increase patient throughput. Ensure all users undergo the required official training to maximize the system's benefits and maintain diagnostic quality. Remember that PIUR tUS Infinity is an adjunct tool; integrate its 3D findings with traditional 2D ultrasound and your clinical judgment for all treatment decisions.
PIUR tUS Infinity is designed for broad compatibility, functioning as a vendor-agnostic add-on that can upgrade most existing 2D ultrasound devices via a digital video output. Its ability to generate structured DICOM SR reports facilitates seamless integration with Picture Archiving and Communication Systems (PACS), streamlining data archiving and access within existing radiology workflows. The planned PowerScribe plug-in will further enhance integration with common reporting platforms.
Details
| Category | Endocrinology & Metabolic AI, Radiology & Imaging AI |
| Pricing | Contact for pricing |
| Deployment | Workstation-based software running on Windows computers, complemented by hardware components (Infinity Sensor, Infinity Video Box). |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated PIUR tUS Infinity received FDA 510(k) clearance (K240036) on September 20, 2024. It is a computer-aided detection device intended to assist medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Radiology |
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Press & Coverage
PIUR IMAGING
PIUR IMAGING Secures u20ac5.6 Million Growth Capital to Scale Tomographic 3D Ultrasound in the USA and Europe
PIUR IMAGING has successfully closed a u20ac5.6M growth capital funding round to expand the commercialization of its AI-powered tomographic 3D ultrasound solutions, including PIUR tUS Infinity, in the USA and Europe. The funding will support market expansion, product integration, and continued development of clinical applications.
2025-07
PIUR IMAGING
PIUR IMAGING Launches PIUR tUS Infinity 4 for Thyroid: A New Benchmark in Tomographic 3D Ultrasound Technology
PIUR IMAGING released PIUR tUS Infinity 4 for Thyroid, an updated tomographic 3D ultrasound solution that offers faster acquisitions, a new user interface, and advanced background image processing to enhance speed, precision, and user experience in thyroid diagnostics. This add-on solution transforms standard 2D ultrasound systems into high-performance 3D imaging platforms.
2024-02
PIUR IMAGING
PIUR IMAGING Receives FDA Clearance for Revolutionary 3D Ultrasound Technology, PIUR tUS Infinity, Now Available in the U.S.
PIUR IMAGING announced that its PIUR tUS Infinity has received FDA clearance, allowing its advanced 3D ultrasound technology to be introduced to the U.S. healthcare market. This system upgrades existing 2D ultrasound devices to provide detailed volumetric datasets, particularly for thyroid imaging.
2024-09
Axis Imaging News
PIUR Imaging Updates AI Thyroid Ultrasound Software to Reduce Workflow Time
PIUR Imaging has released an updated version of its PIUR tUS Infinity-Thyroid software, an AI-powered 3D ultrasound solution designed to reduce thyroid examination time and standardize workflow. The update integrates into radiology workflows with AI-driven automation for image acquisition, annotation, and report generation.
2026-03
TipRanks
PIUR IMAGING Advances Funding Round and U.S. Expansion While Showcasing 3D Ultrasound
PIUR IMAGING is advancing its U.S. expansion plans and promoting its PIUR tUS Infinity solution, an AI-enabled 3D ultrasound platform designed to make exams faster, more consistent, and easier to document. The company is also approaching the closing of its current investment round.
2026-07
Vascular News
PIUR Imaging launches wireless tomographic ultrasound system
PIUR Imaging launched a portable, wireless version of its tomographic ultrasound system, PIUR tUS Infinity, in Europe. This CE-marked device transforms any standard ultrasound into a high-resolution tomographic imaging device, offering 3D volume rendering for various applications.
2019-09
Curium Pharma
Curium and PIUR IMAGING announce thyroid imaging partnership in Germany to enable tomographic 3D ultrasound solutions
Curium and PIUR IMAGING have partnered to advance thyroid diagnostics in Germany, with Curium exclusively distributing PIUR tUS Infinity in nuclear medicine. The PIUR tUS Infinity seamlessly converts standard ultrasound systems into tomographic 3D imaging devices, enhancing workflow efficiency and reproducibility.
2023-10
Oxford Academic (British Journal of Surgery)
Training of diagnostic artificial intelligence in thyroid sonography: how well is deep learning truly learning?
A study evaluated the learning curve of AI for TIRADS classification in thyroid sonography using PIUR tUS Infinity software, demonstrating significant improvement in correct ACR-TI-RADS classification after several rounds of deep learning. The AI-supported ultrasound is a solid tool for thyroid nodule diagnosis in non-inflamed tissue.
2025-05
Videos
Product demos, reviews, and walkthroughs for PIUR tUS Infinity.
PIUR tUS Infinity Training Video - Analyzing Nodules
PIUR IMAGING
Frequently Asked Questions
PIUR tUS Infinity is an AI-powered software platform that upgrades existing 2D ultrasound devices to provide 3D tomographic imaging, integrating seamlessly into your current workflow. It primarily supports thyroid and vascular imaging (e.g., carotid plaque volume, venous mapping), automating analysis, annotation, and report generation to enhance diagnostic efficiency and reproducibility.
PIUR tUS Infinity has received FDA clearance in the U.S. and is a Class IIa medical device under the Medical Device Regulation 2017/745 in Europe, demonstrating its compliance with medical device standards. While specific HIPAA details aren't provided, its integration with PACS for standardized reporting suggests adherence to healthcare data management practices.
PIUR tUS Infinity enhances traditional 2D ultrasound by converting it into 3D tomographic imaging, offering volumetric data comparable to CT or MRI. This reduces operator dependency, standardizes examinations, and significantly cuts scan-to-report time by up to 60% compared to conventional 2D workflows.
The pricing for PIUR tUS Infinity is not publicly disclosed and requires direct contact with PIUR Imaging for a quote. However, its enhanced imaging capabilities may qualify for reimbursement through CPT Category I code 76377 in the United States.
PIUR tUS Infinity acts as a diagnostic support tool and must not be used as the sole source for treatment decisions, requiring physician review and approval of its AI-generated results. It aims to reduce operator variability and streamline workflows, but still requires a physician skilled in ultrasonic diagnosis and knowledge of human anatomy.
PIUR tUS Infinity is designed as an add-on solution that upgrades existing 2D ultrasound devices, making it vendor-agnostic. It works with most ultrasound systems that have a digital video output, requiring an Infinity Video Box, PIUR Sensor, and software license.
The system generates high-resolution 3D datasets using an IMU sensor for tracking probe movement, which helps reduce inter- and intra-observer variability compared to 2D ultrasound. Its AI-powered analysis automates documentation and annotation, and clinicians are prompted to review, adjust, and approve the results, including nodule classification with an integrated ACR-TIRADS calculator.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19
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