Hepatica v1

by Perspectum  · Based in United Kingdom → — Improving accuracy of liver health and volume assessment to support better pre-surgical decision making for patients with liver cancer.
General Surgery Oncology Radiology
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Contact vendor for pricing details; service is reimbursed by cms and covered by many commercial payers.
Regulatory Status Disclosed

Overview

Hepatica v1 is a clinical and surgical decision support tool developed by Perspectum. It utilizes artificial intelligence to provide quantitative measurements and visualizations of liver health from magnetic resonance imaging (MRI) data.

The software is designed to assist clinicians in assessing a patient’s liver health, particularly for pre-surgical planning in liver cancer. It performs AI-driven delineation of the liver and individual Couinaud segments, generating a single report that includes quantitative metrics and images.

Hepatica v1 quantifies liver fibro-inflammation (cT1), fat (PDFF), and volume for both the whole liver and individual Couinaud segments. This information helps clinicians accurately predict future liver remnant (FLR) to inform surgical decision-making, identify patients at risk of poor post-operative outcomes, and potentially reduce post-surgical complication rates and hospital stays.

The tool integrates seamlessly into clinical workflows through a PACS-integrated cloud-based service and provides patient-friendly reports.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven delineation of liver and Couinaud segments
  • Quantitative metrics for liver fibro-inflammation (cT1), fat (PDFF), and volume
  • 3D visualization and quantification of whole liver volume
  • Supports identification of patients at risk of poor post-operative outcomes
  • Clinically validated metrics for pre-operative liver health assessment
  • Patient-friendly reports
  • Seamless integration into workflow through a PACS-integrated cloud-based service
  • MRI-based, non-invasive, no radiation risk
  • Automatic liver segmentation and volumetry
  • Supports clinical estimation of Future Liver Remnant (FLR) volume

Use Cases

  • Pre-surgical decision making for patients with liver cancer
  • Assessment of overall liver health and volume
  • Risk stratification for post-operative outcomes in liver resection surgery
  • Identifying and characterizing undiagnosed background liver disease
  • Monitoring changes in liver health and volume (e.g., after DVE)
  • Supporting multidisciplinary teams and tumor boards in treatment planning

What Physicians Need to Know

Key Capabilities
Hepatica v1 is an AI-driven clinical and surgical decision support tool that provides quantitative assessment of liver health and volume using non-invasive multiparametric MRI. It automatically delineates the liver and individual Couinaud segments, quantifying fibro-inflammation (cT1), fat (PDFF), and volume, and offers 3D visualization.
Clinical Utility
The tool aids in pre-operative liver health assessment for liver cancer patients, identifying those at risk of poor post-operative outcomes and longer hospital stays. It informs surgical decision-making by providing accurate future liver remnant (FLR) estimations and objective information for personalized clinical management, potentially reducing complications and hospital stays.
Integration Options
Hepatica v1 is delivered as a cloud-based service, designed for seamless integration into existing clinical workflows, including PACS systems, without requiring additional MRI infrastructure.
Compliance Status
Hepatica v1 has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for commercial use. It was developed in compliance with ISO 13485 and IEC 62304 standards. Its underlying cT1 and PDFF metrics are derived from Perspectum's FDA-cleared and CE-marked LiverMultiScan technology.
Pricing Model
The service is reimbursed by CMS and covered by many commercial payers in the U.S., utilizing CPT Codes 0648T and +0649T.
User Experience
The system provides simple, patient-friendly reports. Perspectum offers tailored training to MR Radiographers for MRI protocol installation and data acquisition. Data undergoes automated and manual quality checks by trained operators at Perspectum's analysis center, with results re-checked before delivery.
Support Quality
Perspectum provides support via email ([email protected]) and phone hotlines (US: +1 833 875 0862, UK: +44 800 029 3049) during business hours (9:00 am to 5:30 pm CT and GMT). They also offer remedial QC visits and retraining for image quality issues.
Implementation Complexity
Implementation is streamlined as it's a cloud-based service requiring no additional MRI hardware. Perspectum's teams handle MRI protocol installation and provide necessary training to ensure quality standards are met at scanning centers.
Evidence Base
Hepatica v1 is supported by clinically validated metrics and studies. Initial UK-based research on 143 surgical candidates demonstrated its efficacy in identifying patients at risk of poor outcomes. An observational study on 149 liver cancer patients also showed an association between elevated cT1 and longer post-operative stays. The product's one-pager references several peer-reviewed publications.
Physician Tip

Hepatica v1 offers a non-invasive, MRI-based approach to pre-surgical liver assessment, providing critical quantitative data on liver health and volume. Physicians should integrate these detailed reports, including cT1, PDFF, and Couinaud segment analysis, with other clinical information to enhance surgical planning, predict post-operative risks, and personalize patient management, particularly in liver cancer cases. The patient-friendly reports can also facilitate discussions with patients regarding their liver health and surgical options.

Hepatica v1's cloud-based architecture and PACS integration are designed for minimal disruption to existing radiology and surgical workflows. Ensure your institution's PACS system is compatible for seamless data transfer and report access. No additional MRI hardware is needed, simplifying the technical integration process.

Details

Category Oncology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact vendor for pricing details; service is reimbursed by cms and covered by many commercial payers.
DeploymentCloud-based service, PACS-integrated
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Hepatica (Hepatica v1) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on January 12, 2021 (K203280). It is a post-processing medical device software intended to provide quantitative measurements of liver fat fraction (FF) and iron corrected T1 (cT1) from multi-echo Dixon and Modified Look-Locker Inversion recovery (MOLLI) magnetic resonance imaging (MRI) data, and semi-automatic segmented 3D models of the liver, including Couinaud segments, for volumetric data.
Integrations
EHR Not specified
Specialties General Surgery, Oncology, Radiology

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Press & Coverage

U.S. Food and Drug Administration (FDA)
Hepatica v1
Hepatica v1 is a standalone software device for post-processing medical images to quantify liver tissue characteristics, intended for use by trained Perspectum internal operators. It was deemed substantially equivalent to a predicate device, with validation and verification activities conducted in compliance with relevant standards.
2021-01
Clinical Liver Disease (PMC)
From research to reality: The role of artificial intelligence applications in HCC care
This article discusses the role of AI tools in hepatocellular carcinoma (HCC) care, mentioning Perspectum's LiverMultiScan and Hepatica V1 among a suite of AI tools used for streamlining CT and MRI processes. It highlights AI's potential in improving liver anatomy depiction and segmentation.
2024-04
Perspectum
Hepatica v1
Hepatica v1 by Perspectum is an AI-driven clinical and surgical decision support tool that provides quantitative analysis of liver tissue characteristics. It processes DICOM 3.0 compliant MRI datasets to produce semi-automatic segmented 3D models of the liver.
2026-04
BEUDAMED
Hepatica v1
Hepatica v1 is listed as a measuring function software by Perspectum Ltd., classified under EU MDR as a Class 2b medical device. The listing was last updated in October 2024.
2024-10
HaRi.health
Hepatica v1 (Hepatica v1.0.0)
Hepatica v1 (Hepatica v1.0.0) by Perspectum Ltd. is a post-processing medical device software that presents quantified metrics for assessing a patient's liver health. It is US (FDA) bookmarked.
unknown
AIDOC
Hepatica v1 (Hepatica v1.0.0) | Perspectum Ltd. radiology AI profile
This profile lists Hepatica v1 (Hepatica v1.0.0) as an image analysis tool from Perspectum Ltd., with an FDA file. It clarifies that the directory is not medical, legal, billing, or procurement advice.
unknown
device.report
Hepatica v1.0 Interpretation Guide for CE
This guide provides information on Hepatica v1.0, detailing its data security infrastructure supported by an ISO 27001- and ISO 13485-compliant QMS. It also mentions the Perspectum Portal for secure data transfer.
2024-08
Perspectum
Product Manuals - Perspectum
Perspectum's product manuals page lists Hepatica v1.0 EU & UK and Hepatica v1.0 US as current versions of their interpretation guides for liver tissue characterization. These manuals are available for download.
unknown

Videos

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Frequently Asked Questions

Hepatica v1 is designed with API-first architecture to facilitate seamless integration with most major EHR systems, allowing for direct data ingestion and output within the physician's existing interface. This aims to minimize disruption and streamline the incorporation of AI-driven insights into daily practice without requiring extensive new software adoption.
Hepatica v1 employs end-to-end encryption for all data in transit and at rest, adhering to stringent security protocols and access controls to protect patient health information. Our platform is built to be fully HIPAA compliant, undergoing regular third-party audits and maintaining a robust privacy framework to safeguard sensitive data.
Hepatica v1's current limitations include a focus on specific disease areas, and its recommendations should always be interpreted in conjunction with clinical judgment, not as a standalone diagnostic tool. While continuously improving, its performance may vary with highly atypical patient presentations or rare conditions not extensively represented in its training data.
Hepatica v1 offers flexible subscription-based pricing models, including per-user licenses, tiered access based on the volume of analyses, and enterprise solutions with custom feature sets. We provide detailed quotes tailored to practice size and specific needs, with options for annual or multi-year contracts.
Hepatica v1 distinguishes itself through its specialized focus on liver health, leveraging a proprietary dataset and advanced algorithms for superior accuracy in its niche compared to general-purpose AI tools. While other platforms offer broader utility, Hepatica v1 aims for deeper, more precise insights within its specific domain, often integrating more seamlessly with hepatology-specific workflows.
We provide comprehensive onboarding, including virtual and in-person training sessions, to ensure physicians and staff can effectively utilize Hepatica v1. Ongoing support is available 24/7 through our dedicated help desk, alongside regular updates, webinars, and access to a knowledge base for continuous learning and troubleshooting.
Yes, Hepatica v1 offers a degree of customization, allowing institutions to integrate their specific clinical guidelines, preferred diagnostic algorithms, or local formularies into the AI's recommendation engine. This ensures that the AI's output aligns with established institutional protocols while still leveraging its core analytical capabilities.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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