Terumo Health Outcomes Now Offers FDA-Cleared Medis QFR® 3.0 Software for Coronary Physiology Assessment in the US

Rhea-AI Summary

Terumo Health Outcomes (THO) has announced the U.S. availability of Medis QFR 3.0, an FDA-cleared software solution for coronary physiology assessment, through its collaboration with Medis Medical Imaging. The AI-powered software aims to enhance catheterization laboratory efficiency and patient comfort.

The technology has been extensively validated through over 200 peer-reviewed publications, with data from more than 17,000 patients and 20,000 lesions. Notably, QFR received recommendation from the European Society of Cardiology in their 2024 ESC Guidelines. THO will showcase QFR 3.0 at the upcoming SCAI 2025 Scientific Sessions.

This software integrates with THO's ePRISM platform, which provides predictive insights for patient risk assessment and treatment optimization, potentially reducing hospital costs and recovery times.

Positive

• FDA clearance obtained for Medis QFR 3.0 software
• Strong clinical validation with 200+ peer-reviewed publications
• ESC Guidelines recommendation received in 2024
• Integration with existing ePRISM platform enhances product ecosystem
• Potential for reduced hospital costs and recovery times

Negative

• None.

 – Innovative AI software supports hospital adoption of advanced tools to improve cath lab workflow and patient comfort –

SOMERSET, N.J., April 16, 2025 /PRNewswire/ -- Terumo Health Outcomes (THO), a division of Terumo Interventional Systems (TIS), today announced that Medis QFR 3.0, an FDA-cleared software solution for coronary physiology assessment, is now available in the United States through its collaboration with Medis Medical Imaging. This milestone builds on the companies' December 2023 partnership announcement.

"Helping hospitals access proven, innovative tools like QFR 3.0 is an important part of our mission," said Ryan Graver, Senior Divisional Vice President, THO. "This latest advancement from Medis aligns with the goals of many hospitals to enhance cath lab efficiency and support high-quality, patient-centered care. We are proud to be able to offer this cardiology diagnostic software solution to our customers."

THO and Medis will showcase QFR 3.0 during the upcoming SCAI 2025 Scientific Sessions, offering clinicians the opportunity to learn more about the technology and its role in supporting efficient, physiology-guided care in the cath lab.

Medis QFR has been validated through extensive clinical research, including over 200 peer-reviewed publications and data from more than 17,000 patients and 20,000 lesions. In 2024, QFR was recommended by the European Society of Cardiology in their ESC Guidelines, reinforcing its clinical relevance and utility.

"We're excited that U.S. hospitals will now have access to QFR 3.0," said Dr. Maya Barley, CEO of Medis Medical Imaging. "Our continued collaboration with Terumo Health Outcomes supports our goal of delivering solutions that simplify workflow while maintaining a strong foundation of clinical accuracy."

"This partnership reflects our shared commitment to expand hospital access to innovative cardiovascular technologies," said Ghada Farah, President of Terumo Interventional Systems.

THO is a division of TIS, which offers a portfolio of high-quality interventional devices that complement the predictive insights offered by THO's ePRISM platform. While ePRISM assists clinicians in identifying patient risk and optimizing treatment strategies, the advanced tools from TIS support procedural efficiency, contributing to improved patient outcomes. This combination assists clinicians to make more informed decisions, facilitating smoother procedures and potentially reducing hospital costs and recovery times.

About Terumo Health Outcomes
Terumo Health Outcomes (THO) delivers advanced digital health solutions that empower clinicians with predictive insights to optimize patient care and hospital efficiency. The ePRISM platform helps provides personalized patient care, which is provided to the clinician on a screen in real-time as a decision support tool, enabling hospitals to implement data-driven care strategies that enhance patient outcomes and streamline operational performance. Learn more at www.terumohealthoutcomes.com.

About Terumo
Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for over 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. More information can be found at www.terumo.com.

About Medis Medical Imaging
For over 35 years, Medis has been providing innovative, robust, and extensively validated tools to the medical community worldwide. The heritage and core values are based on this strong purpose of contributing to a healthier society by providing the right tools to cardiologists, radiologists, researchers, and industry partners. Medis' software is internationally appreciated due to its ease of use and its clinical outcome for the patients. At Medis, quality is key. All products are developed and validated extensively to guarantee the highest quality, without compromise. They continuously focus on the creation of clinically relevant innovative software solutions in the cardiovascular imaging domain.

 

 

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SOURCE Terumo Health Outcomes

FAQ

What clinical validation does Medis QFR 3.0 software (TRUMY) have?

The software has been validated through 200+ peer-reviewed publications, data from 17,000+ patients and 20,000+ lesions, and received ESC Guidelines recommendation in 2024.

How will Medis QFR 3.0 benefit hospitals using Terumo (TRUMY) systems?

It enhances cath lab efficiency, supports patient-centered care, and integrates with ePRISM platform for improved decision-making and potentially reduced costs.

When will Terumo (TRUMY) showcase the QFR 3.0 software to clinicians?

The software will be showcased at the SCAI 2025 Scientific Sessions.

What regulatory approvals has Terumo's (TRUMY) Medis QFR 3.0 received?

The software has received FDA clearance for coronary physiology assessment in the United States.