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Cardiac CT’s PROMISE, Faster Reports, and Gadoquatrane NDA
August 28, 2025
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Together with
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“The adoption of coronary computed tomography angiography is growing in the United States …. In our clinic, coronary CT is a first-line test for individuals who first present with chest pain and no known coronary disease.”
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Victor Marinescu, MD, of Midwest Cardiovascular Institute in a recent webinar on cardiac CT imaging.
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As breast imaging grows more complex, radiology teams need more than siloed tools. Join AGFA HealthCare and special guest Jay P. Patel, MD, of Quantum Radiology at 2 pm ET on September 9 for a webinar on transforming breast imaging workflows in the enterprise imaging era.
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Coronary CT angiography works just as well as traditional stress testing over the long haul for patients with stable symptoms of coronary artery disease. That’s according to the latest follow-up data from the PROMISE study in JAMA Cardiology, which found no difference in mortality between either strategy.
PROMISE was a randomized controlled trial that compared patient work-up with anatomical CCTA scans to functional stress testing (exercise ECG, stress echo, or stress nuclear) in 10k patients from 2010 to 2014.
- The first PROMISE results found that in patients with CAD symptoms who were followed up for just over two years, there was little difference between anatomical CCTA and functional stress testing for endpoints like death, myocardial infarction, or other complications.
But what about over a longer follow-up period? The new results extend PROMISE’s follow-up to a median of 10.6 years, finding…
- Mortality rates were largely the same whether patients got CCTA or stress testing (14.3% vs. 14.5%, p = 0.56).
- Cardiovascular mortality rates were also similar (4.0% vs. 4.3%, p = 0.77).
- As were noncardiovascular death rates (10.7% for both).
There were some differences in the predictive power of each modality based on patient characteristics…
- With CCTA, any abnormal finding increased a patient’s mortality risk compared to normal findings for severe, moderate, and mild disease (HR = 3.44, 3.38, and 1.99, respectively).
- With stress testing, only patients with severely abnormal disease had higher mortality risk (HR = 1.45).
The new PROMISE data also tracks well with recent 10-year findings from SCOT-HEART, another major study that demonstrated CCTA’s value.
- Combining results from PROMISE and SCOT-HEART shows 89% survival of patients with stable angina at 12 years, demonstrating good effectiveness regardless of workup strategy.
The Takeaway
PROMISE findings have gone a long way toward showing that CCTA is every bit as effective as stress testing, and the new results reinforce this message. The findings are also good news for radiology, which has a stronger hold over anatomical imaging with CT than it does over the predominant stress modalities, which are largely controlled by cardiology.
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Mobile X-Ray Designed for Going Places
The Philips Radiography 7000 M mobile radiography system was designed for going places. Read how technologists at the University of Vermont Medical Center rely on its long battery life to go a whole shift without re-charging.
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AI-Assisted Fracture Detection
Gleamer’s BoneView AI solution helped radiologists detect fractures on radiographs of both adults and children in a meta-analysis of eight studies. Discover how it can help your practice today.
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A Bold Transformation in Client Experience
Intelerad is transforming how it supports customers and partners with clients through a company-wide Client Obsession initiative. The company is making investments in new tools, technologies, and staff to remove friction and deliver value – find out how it works on this page.
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- Patients Are Getting Reports Faster: Patients are getting their radiology reports much more quickly, thanks to the 21st Century Cures Act’s requirements to immediately release patient results. A new study in JAMA Network Open documents the trend, with Mayo Clinic researchers analyzing report delivery times for 324k outpatient and inpatient radiology reports before and after the act went into effect. Report access times fell significantly for both inpatients (2.8 vs. 9.1 hours) and outpatients (1.1 vs. 4.9 hours).
- FDA Accepts NDA for Bayer’s Gadoquatrane: The FDA accepted a New Drug Application from Bayer for its gadoquatrane high-relaxivity macrocyclic MRI contrast agent. High-relaxivity agents let radiologists use less contrast to achieve image quality comparable to conventional agents, reducing patient exposure to gadolinium. In the QUANTI clinical trials, researchers showed gadoquatrane could be used at a dose of 0.04 mmol Gd/kg of body weight, a 60% reduction. Gadoquatrane is also under review in Japan, the European Union, and other countries.
- Brazilian Woman Dies After CT Scan: In a tragic development in Brazil, a 22-year-old woman died after a CT scan when she developed anaphylactic shock due to an allergic reaction to contrast media. Leticia Paul had a history of kidney stones and was getting the scan as part of a routine check. Fatal accidents during imaging exams are extremely rare, but Paul’s death follows that of a New York man who was killed in an MRI accident in July.
- CT Finds COPD in Dairy Farmers: Environmental exposure on dairy farms can cause a form of chronic obstructive pulmonary disease that’s distinct on CT. Writing in Respiratory Medicine, researchers scanned 85 people including smoking and non-smoking dairy farmers as well as smokers who didn’t have occupational exposure. Non-smoking dairy farmers had lower emphysema rates (54% vs. 80-81%) and fewer smoking-related features like airway enlargement with fibrosis, but had the highest mucus plug scores of the three groups (1.17 vs. 0.37-0.80).
- Responding to Screening Skeptics: One of the arguments raised against population-based screening is that it doesn’t reduce all-cause mortality. But a JAMA Network Open study claims all-cause mortality is not an appropriate measure of screening’s success. Researchers reviewed major screening randomized controlled trials, separating mortality rates between those caused by the target cancer and those from other causes (off-target mortality). Off-target mortality was only around 1% higher for screened people, not enough to offset screening’s demonstrated cancer mortality reduction (11% for mammography, 23-33% for lung screening).
- Optellum Debuts Thoracic Foundation Model: Optellum this week launched a new AI foundation model based on thoracic CT scans that’s designed to detect and manage lung diseases. Optellum’s model is trained on chest CT images from large-scale, diverse datasets, such as the University of Oxford-led DART project. The model can perform multiple clinical tasks, from diagnosis and risk stratification to patient monitoring, and Optellum will use it to create new AI models to be deployed on its LungOS platform.
- Imagion Secures Funding Commitments: MRI contrast developer Imagion Biosystems has secured funding worth US$2.3M from Australian investors to fund further development of its MagSense technology. Imagion will fund a Phase 2 trial of MagSense for its lead indication of detecting HER2 breast cancer, as well as Phase 1 trials for additional indications for prostate and ovarian cancer. Separately, the company began a collaboration with Wayne State University to optimize MagSense dosing as well as MRI sequences and protocols using MRI scanners from Siemens Healthineers.
- Philips Updates Cardiac Ultrasound Line: Philips launched an update of its cardiovascular ultrasound scanners on the eve of this week’s ESC 2025 meeting. Transcend Plus is an upgrade to the company’s EPIQ CVx and Affiniti CVx scanners that includes advancements in 2D and 3D cardiovascular image quality as well as AI tools ported over from Philips’ acquisition of DiA Imaging Analysis. Recently cleared enhancements include 2D Auto EF and 2D Auto EF Advanced for calculating ejection fraction, as well as additional support for ultrasound contrast imaging.
- Sonio Launches New Maternal-Fetal AI Options: Sonio has segmented its flagship AI software for maternal-fetal medicine (also called Sonio) to create new price points. Sonio Start, Sonio Plus, Sonio Premium, and Sonio Enterprise are designed to offer a range of options from entry-level to enterprise usage. The company said the new options were developed with the U.S. market in mind, and include telehealth capabilities to improve communication and collaboration between providers. Sonio was acquired by Medison in 2024.
- HeartFocus Begins U.S. Shipments: French software developer DESKi started shipping its HeartFocus solution that enables healthcare professionals to perform AI-guided cardiac ultrasound scans with just a few hours of training. HeartFocus got FDA clearance in April, and DESKi raised $6M shortly after to support U.S. and international product launches. HeartFocus will initially be available on Butterfly Network’s handheld ultrasound scanners and can be accessed in the company’s Butterfly Garden app store.
- Leqembi Sales Begin in Europe: Sales of the Alzheimer’s drug Leqembi have begun in the European Union, first in Austria and next month in Germany. Leqembi was developed by pharmaceutical firms Eisai and BioArctic and targets buildup of amyloid plaque and tau in the brain. PET can be used to monitor Leqembi treatment, and the drug’s U.S. launch has spurred interest in a new generation of dedicated PET brain scanners from companies like United Imaging, Shimadzu, and Positrigo, as well as PET radiotracers for detecting amyloid.
- Brain PET Scanner Gets FDA Nod: Another dedicated brain PET scanner could be hitting the U.S. market after South Korean medical device firm Brightonix Imaging received FDA 510(k) clearance for its Pharos PET camera. In addition to brain imaging, Pharos can be used for breast and extremity applications thanks to its movable detector and seat that enables patients to be imaged in both lying and seated positions.
- Lunit Touts Growth in Italy: Lunit is highlighting strong growth of its AI solutions in Italy, where the company’s technology is now being used at health systems serving 14% of the country’s population. As of June, more than 10 local health authorities serving 8.5M people were using Lunit’s products, including Insight MMG for mammography and Insight CXR for chest X-ray. The growth shows how AI can be adopted at scale in healthcare. Contracts covering 4M more people are expected by year-end.
- Core Sound Buys UltraLinQ: Medical imaging workflow developer Core Sound Imaging is putting the $80M in funding it raised in 2024 to work, acquiring UltraLinQ Healthcare Solutions. UltraLinQ develops cloud-based PACS and cardiac monitoring solutions, and the acquisition will make Core Sound’s Studycast platform available to a broader array of hospitals by giving it access to UltraLinQ’s installed base.
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Start at the Source to Improve MRI
Looking for ways to improve MRI speed and image quality while addressing broader concerns in healthcare? The answer may lie in proven MRI physics in your existing scanner – learn how to unlock it with STAGE from SpinTech MRI.
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The Transformative Role of AI in Radiology
In this episode of The Radiology Report Podcast, Medality’s Daniel Arnold sits down with Dr. John Simon, who shares his insights into the transformative role of AI in radiology and its ability to enhance efficiency, improve patient care, and unlock new diagnostic possibilities.
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AI for Lung Cancer Diagnosis and Screening
Check out this comprehensive new eBook from Calantic by Bayer on the role of AI in lung cancer diagnosis and screening. It explores AI’s potential role in improving lung cancer screening strategies, identifying high-risk individuals, and enhancing diagnostic accuracy. Download it today.
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- Redefining Breast Imaging in the Enterprise Era: As breast imaging grows more complex, radiology teams need more than siloed tools. Join AGFA HealthCare and breast imaging and IT experts for this September 9 webinar about transforming breast imaging workflows in the enterprise imaging era.
- A New Benchmark for Tomo Imaging: There’s a new benchmark for digital breast tomosynthesis 3D images with MAMMOMAT B.brilliant from Siemens Healthineers. The system’s 50° wide-angle tomosynthesis helps you achieve excellent outcomes for your patients, radiologists, and breast care professionals.
- Heart Failure Diagnosis with AI Handheld Echo: A new study showcases the power of AI to transform heart failure diagnosis. Discover how AI from Us2.ai accurately detected left ventricular ejection fraction (LVEF ≤ 40%) on handheld echo with high diagnostic accuracy, closely matching expert human analysis.
- New-generation Platform for Managing Multi-Omics Data: QP-Insights from Quibim is a new-generation advanced platform for the management, storage, and analysis of large-scale multi-omics data and medical images for clinical studies and research projects. Learn more on this page.
- Presenting Unboxing AI: Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on August 28 features Luke Bideaux of Vega Imaging Informatics – reserve your seat today.
- The Evolution of PACS: PACS has become the backbone of efficiency in modern radiology, evolving into sophisticated enterprise-wide imaging solutions. Discover how Intelerad’s IntelePACS can deliver the innovation, intelligence, and flexibility your imaging strategy needs by booking a demo.
- Experience the Power of Workflow Orchestration: Mach7’s UnityVue Workflow Orchestration Platform is a groundbreaking new solution that creates a unified view of patient imaging data, speeding patient care delivery, creating more efficient workflows, and reducing radiologist stress. Experience the power of UnityVue for yourself.
- How to Standardize CT Images: The quality and appearance of CT scans can vary considerably. In this white paper from Riverain Technologies, find out how image normalization can standardize CT images, making them easier to analyze and interpret.
- The Advantages of Cloud-Based PACS: CloudPACS offers significant advantages to healthcare providers for enterprise imaging, including no on-premise requirements and enhanced reliability. Learn more about the advantages of CloudPACS in this talk from HIMSS 2025 by Visage Imaging’s Steve Deaton.
- AI and Neuroradiology Workflow: How can AI add value to workflows in neuroradiology? Watch this on-demand video to learn from Blackford partners how AI can help, from assisting providers in managing acute stroke patients to the impact of CPT III codes in driving adoption of brain volumetric AI solutions.
- Planning for Data Migration Success: When UCSF Health’s enterprise imaging team needed to bring two new hospitals into their network, a new data migration project was born. Watch this on-demand webinar to learn how UCSF ensured a successful migration by working with Laitek, an Enlitic company.
- AI-Powered Population Health: DeepHealth closed its acquisition of iCAD, a major step in DeepHealth’s vision to build the future of AI-powered population health. In this Imaging Wire Show, we talked to company executives Kees Wesdorp and Niccolo Stefani about the acquisition and their strategic roadmap.
- Denoising AI’s True Potential for Medical Imaging: What is AI’s true potential in medical imaging? Find out in this American Hospital Association podcast with United Imaging CEO Jeffrey Bundy, PhD, and United Imaging Intelligence CEO Terrence Chen, PhD.
- Elevating Generative Reporting to the Web: Learn about the next leap in patient-focused diagnostic imaging with KailoFlow, the web-based evolution of Kailo Medical’s generative structured reporting platform that combines progress, innovation, and accessibility.
- Building an Enterprise Imaging Ecosystem: What’s the best way to bring smaller clinics and rural hospitals into your enterprise imaging ecosystem? Find out how MultiCare Health System did it in this white paper from Merge.
- Unprecedented Insights Made Possible with AI: With the largest normative dataset of whole-body imaging in the world, Prenuvo’s AI researchers partner with the best academic minds to understand – like never before – what “normal” aging means. Learn about their work today.
- Optimize Radiology Workflows: Harness cloud and AI technology to help your radiology teams unlock insights, increase efficiencies, and improve patient care. Learn more about an integrated approach to AI in radiology in this e-book from Microsoft.
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