E-Scopics’ Hepatoscope Wins FDA Nod for Spleen Exam Workflow

E-Scopics, a company advancing ultrasound access at the point of care, has received U.S. Food and Drug Administration (FDA) clearance of new enhancements to its Hepatoscope platform.

Hepatoscope now features a dedicated Spleen Exam workflow, which expands its utility in non-invasive assessment of complications of cirrhosis. The system uses optimized acquisition parameters, including an adjusted vibration frequency and region of interest tailored to spleen anatomy, which the company said improves the reliability of high stiffness values.

Thanks to this clearance, Hepatoscope became the first ultraportable liver assessment solution that complies with the international IEC 63412-1 standard for the mapping of tissue stiffness and is capable of real-time elastography imaging.

The software-based ultrasound imaging and quantification platform was first launched on Windows OS laptops and is now also compatible with macOS systems. Laptops with Apple M3 chips or later and macOS 14 Sonoma can now serve as hosts for Hepatoscope, providing more flexibility in deployment and simplifying implementation across diverse IT departments.

Hepatoscope also introduces deeper integration into clinical workflows through conformity with the HL7 FHIR R4 standard, enabling direct connectivity with electronic health record (EHR) systems. Operators can securely log in, access appointment schedules, select patients directly from institutional worklists and automatically export exam reports to the EHR upon completion.

“Elastography plays an essential role in evaluating the severity of chronic liver diseases by measuring how shear waves propagate through tissue such as the liver and spleen,” said Claude Cohen-Bacrie, founder and CEO of E-Scopics. “The compliance with the IEC 63412-1 standard imposes clear explanations about shear wave propagation speed measurements and optimal visualization of 2DTE. Hepatoscope is now the only ultraportable ultrasound system with both real-time ultrasound imaging plus tissue elasticity imaging, for liver and spleen assessment, at the point of care.”

Hepatoscope was first released in the U.S. in 2024.