E-Scopics Secures FDA Clearance for Enhanced Hepatoscope® Platform
E-Scopics has announced a major advancement in liver disease diagnostics with the latest U.S. clearance from the U.S. Food and Drug Administration for its upgraded Hepatoscope platform. This milestone reflects the company’s continued innovation in non-invasive diagnostic technology and strengthens its position as a global leader in point-of-care ultrasound solutions for liver disease assessment.
The newly approved enhancements significantly expand Hepatoscope’s capabilities, particularly in managing complications associated with chronic liver conditions. These updates include advanced elastography imaging, a dedicated spleen examination workflow, improved software compatibility, and seamless integration with healthcare IT systems. The company will showcase these developments at Digestive Disease Week 2026, scheduled to take place in Chicago from June 3 to 5.
Expanding Clinical Utility with Spleen Assessment
One of the most notable additions to the Hepatoscope platform is the introduction of a dedicated spleen examination workflow. This feature is designed to enhance the non-invasive evaluation of complications arising from cirrhosis, a condition that often affects both the liver and spleen.
The updated system incorporates optimized acquisition parameters specifically tailored to spleen anatomy. Adjustments such as refined vibration frequency and targeted regions of interest improve the accuracy and reliability of stiffness measurements, especially in cases where high stiffness values are observed. These improvements are crucial for clinicians monitoring portal hypertension and other cirrhosis-related complications.
By enabling spleen stiffness assessment alongside liver evaluation, Hepatoscope provides a more comprehensive diagnostic picture. This integrated approach allows healthcare providers to better understand disease progression and tailor treatment strategies accordingly.
Real-Time Imaging Enhances Point-of-Care Diagnostics
A defining strength of Hepatoscope lies in its ability to combine real-time ultrasound imaging with transient elastography in a single portable device. This dual capability allows clinicians to perform immediate assessments at the patient’s bedside, whether in hospital settings, outpatient clinics, or private practices.
According to Dr. Olivia Pietri, a hepato-gastroenterologist based in Marseille, the system’s portability and real-time imaging features make it highly practical for everyday clinical use. The ability to assess spleen stiffness under direct image guidance is particularly valuable, as it opens new avenues for evaluating cirrhotic patients more proactively.
This real-time functionality not only enhances diagnostic accuracy but also improves workflow efficiency. Clinicians can make quicker decisions, reduce the need for additional imaging procedures, and provide more timely care to patients.
Compliance with International Elastography Standards
Another major highlight of the upgraded Hepatoscope platform is its compliance with the international IEC 63412-1 standard for ultrasound elastography. This standard defines best practices for mapping tissue stiffness and ensures optimal visualization of variations across different levels of liver stiffness.
By adhering to this rigorous benchmark, Hepatoscope delivers improved imaging precision, enabling clinicians to detect even subtle changes in tissue stiffness. This capability is particularly beneficial for monitoring treatment response and disease progression over time.
The implementation of this standard also ensures consistency and reproducibility in measurements, which are critical for clinical decision-making. With this achievement, Hepatoscope becomes the first ultraportable liver assessment solution to meet such demanding regulatory requirements while offering real-time elastography imaging.
Advancing Elastography Technology for Better Outcomes
Elastography plays a vital role in evaluating chronic liver diseases by measuring how shear waves propagate through tissue. These measurements provide insights into tissue stiffness, which is a key indicator of fibrosis and other pathological changes.
Claude Cohen-Bacrie, founder and CEO of E-Scopics, emphasized the importance of this technology in modern hepatology. He noted that compliance with the IEC standard requires precise measurement of shear wave propagation speed and clear visualization of tissue elasticity.
Hepatoscope’s ability to integrate real-time ultrasound imaging with tissue elasticity mapping sets it apart from other devices in the market. It is currently the only ultraportable system that offers both functionalities for liver and spleen assessment at the point of care. This combination enhances diagnostic confidence and supports more informed clinical decisions.
Enhanced Software Compatibility for Broader Adoption
Initially launched on Windows-based laptops, the Hepatoscope platform has now expanded its compatibility to include macOS systems. This update allows healthcare providers to use Apple devices equipped with M3 chips or later, running macOS Sonoma or newer.
This cross-platform flexibility simplifies deployment across diverse healthcare environments. Institutions can integrate Hepatoscope into their existing IT infrastructure without requiring significant hardware changes, making it easier to adopt and scale.
The ability to run on widely used operating systems also improves accessibility for clinicians, ensuring that the technology can be utilized in various clinical settings, from large hospitals to smaller community practices.
Seamless Integration with Electronic Health Records
In addition to hardware and imaging improvements, Hepatoscope now offers enhanced connectivity with electronic health record (EHR) systems. The platform complies with the HL7 FHIR R4 standard, enabling secure and efficient data exchange within healthcare networks.
This integration allows clinicians to log in securely, access patient schedules, and select individuals directly from institutional worklists. Once an examination is completed, reports can be automatically generated and uploaded to the EHR system.
These capabilities significantly reduce administrative workload, streamline clinical workflows, and improve overall efficiency. By minimizing manual data entry and ensuring accurate record-keeping, Hepatoscope supports a more seamless healthcare experience for both providers and patients.
Supporting Modern Healthcare Needs
The latest enhancements to Hepatoscope reflect a broader trend toward more accessible, efficient, and patient-centered healthcare solutions. Non-invasive diagnostic tools like Hepatoscope are increasingly important in managing chronic conditions such as liver disease, where early detection and continuous monitoring are critical.
By combining portability, advanced imaging, and digital integration, E-Scopics is addressing key challenges in modern healthcare. The platform enables clinicians to deliver high-quality care in a variety of settings while reducing reliance on invasive procedures.
Showcasing Innovation at DDW 2026
E-Scopics will present the upgraded Hepatoscope platform at Digestive Disease Week 2026, one of the leading global events for professionals in gastroenterology and hepatology. The exhibition will provide an opportunity for clinicians, researchers, and industry leaders to explore the system’s capabilities firsthand.
The company’s presence at this event underscores its commitment to advancing medical technology and fostering collaboration within the healthcare community.
The FDA clearance of Hepatoscope’s new features marks a significant step forward in non-invasive liver disease diagnostics. With its expanded capabilities, including spleen assessment, advanced elastography imaging, international standard compliance, and improved software and EHR integration, the platform sets a new benchmark in point-of-care ultrasound technology.
E-Scopics continues to push the boundaries of innovation, delivering solutions that enhance clinical practice and improve patient outcomes. As liver disease remains a global health challenge, technologies like Hepatoscope are poised to play a crucial role in transforming how these conditions are diagnosed and managed.
About E-Scopics
E-Scopics S.A.S is a French medtech company that advances the accessibility, affordability and ease of use of premium ultrasound tools at the point of care. Its agile software platform has dematerialized and automated ultrasound imaging technologies, creating an Ultrasound-as-a-Service model with specific applications sold via pay-per-use or subscription business models. The company’s first product, Hepatoscope, leverages quantitative imaging capabilities to help clinicians assess liver fibrosis, steatosis, and liver disease complications non-invasively at the bedside
