MENLO PARK, Calif. — March 11, 2026 — Subtle Medical, a leader in AI-powered medical imaging software, today announced its participation in NVIDIA GTC 2026, taking place in San Jose, California, March 16-19. At this year’s conference, Subtle Medical will present two technical posters highlighting how SubtleHD™-enhanced data improves downstream accuracy and a foundation model for MRI data standardization.

Subtle Medical has been a long-standing partner of NVIDIA, and was the first recipient of the NVIDIA Inception Award in the healthcare category in 2018. Since then, the two companies have collaborated closely to accelerate AI development and deployment in medical imaging, leveraging NVIDIA’s GPU platforms to bring clinically validated AI solutions into real-world healthcare environments.

“At NVIDIA GTC 2026, we’re excited to share how advances in accelerated computing and AI infrastructure are enabling faster model development, improved clinical performance, and scalable deployment of medical imaging AI,” said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical.

Poster Presentations at NVIDIA GTC 2026

1. A Vision-Language Foundation Model for MRI Data Standardization

Subtle Medical will present a vision-language foundation model designed to standardize MRI metadata across sites, vendors, and protocols, addressing one of the most persistent challenges facing enterprise providers with multiple imaging centers. The team will also evaluate how different training environments, including NVIDIA’s cloud infrastructure (BREV), impact the ability to iterate during model development.

Key highlights:

• Trained a vision-language model (SubtleNG™) to harmonize MRI metadata across heterogeneous clinical environments
  
  
• Compared training performance across three configurations:
  
  
  • Local servers with NVIDIA V100 GPUs
    
    
  • Local servers with NVIDIA A100 GPUs
    
    
  • NVIDIA cloud infrastructure (BREV) using H100 GPUs
    
    
• Training on NVIDIA BREV with H100s was 8.8× faster than the best local configuration, enabling full model training in under one day
  
  
• Achieved 99% accuracy while reducing metadata heterogeneity by 71%, improving the consistency of cases read by radiologists across different sites.
  
  

2. Efficient SubtleHD-Enhanced MR Images for Improved Dementia Classification

This poster examines how AI-enhanced MR images and optimized inference pipelines improve both clinical performance and operational efficiency in dementia classification models.

Key highlights:

• Compared dementia classification models trained on standard MR images versus SubtleHD-enhanced images
  
  
• Evaluated TensorRT-optimized inference on:
  
  
  • NVIDIA RTX 2080 Ti
    
    
  • NVIDIA A100 GPUs
    
    
• TensorRT accelerated inference by 3.1× to 5.7×, enabling faster turnaround times for clinical workflows
  
  
• SubtleHD-enhanced training data improved model performance, allowing for more accurate classification of dementia cases:
  
  
  • Standard imaging AUC: 0.951
    
    
  • SubtleHD-enhanced AUC: 0.968

Subtle Medical’s AI solutions, SubtleHD™(MR), SubtlePET™, SubtleSYNTH™, and SubtleALIGN™ are deployed in thousands of scanners worldwide, enabling hospitals and imaging centers to improve image quality and speed on existing MRI and PET scanners. Faster and higher quality imaging leads to increased patient volume, higher revenue, and a better patient experience. To learn more about Subtle’s suite of products, visit www.subtlemedical.com. 

About Subtle Medical, Inc.

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World’s Top Healthcare Company (2025) and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company’s solutions are deployed on over 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improve image quality, and enhance patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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Anna Menyhart-Borroni

Head of Marketing

anna@subtlemedical.com

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MENLO PARK, Calif. — March 3, 2026 — Subtle Medical, a leader in AI-powered medical imaging software, today announced its participation in the European Congress of Radiology (ECR) 2026, taking place March 4–8 in Vienna, Austria. At this year’s congress, Subtle Medical will present fourteen presentations (oral and posters) highlighting advances in AI-driven image enhancement, synthesis, and standardization across MRI and PET imaging, as well as early research supporting the company’s expansion into CT as a new modality.

The presentations demonstrate how Subtle Medical’s AI technologies improve image quality and clinical confidence across diverse scanners, protocols, and patient populations. By addressing challenges such as image noise, contrast limitations, protocol variability, and multi-site heterogeneity, Subtle’s research underscores how AI can support more reliable diagnosis, improved lesion visualization, and greater operational efficiency while preserving existing clinical workflows. See the full presentation schedule here. 

Several presentations at ECR will also highlight Subtle Medical’s collaboration with Bracco, a global leader in diagnostic imaging. These Bracco-sponsored presentations will explore the clinical value of AI-enabled contrast boosting with AiMIFY™, demonstrating how advanced image enhancement AI can improve lesion conspicuity, diagnostic confidence, and workflow efficiency in contrast-enhanced imaging.

Subtle Medical’s AI solutions, SubtlePET™ and SubtleHD™(MR), SubtleSYNTH™,  and SubtleALIGN™ (all three part of the Subtle-ELITE™ package), are deployed in thousands of scanners worldwide, enabling hospitals and imaging centers to improve image quality and speed on existing MRI and PET scanners. Faster and higher quality imaging leads to increased patient volume, higher revenue, and a better patient experience. To learn more about Subtle’s suite of products or meet the team at ECR, request a meeting at https://subtlemedical.com/contact/. 

About Subtle Medical, Inc.

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World’s Top Healthcare Company (2025) and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company’s solutions are deployed on over 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improve image quality, and enhance patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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Anna Menyhart-Borroni

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anna@subtlemedical.com

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MENLO PARK, Calif., Nov. 26, 202 /PRNewswire/ — Subtle Medical, a leader in AI technology for faster and higher quality medical imaging, is set to showcase its latest innovations at the 2025 Radiological Society of North America (RSNA) conference. The company recently announced doubling their growth in 2025, now with over 1,000 scanners deployed with Subtle’s software worldwide. 

Subtle Medical delivers an industry-leading portfolio of third-party image enhancement solutions. The Subtle-ELITE™ Suite – SubtleHD™, SubtleSYNTH™, and SubtleALIGN™ – accelerates MRI and elevates image quality, reducing scan times by up to 80% and helping increase diagnostic confidence. Global adoption of SubtlePET™ continues to grow, enabling faster, lower-dose PET imaging.

Subtle’s solutions are commercially available in the US, EU, UK, Canada, Brazil, and other markets worldwide. They are already helping leading health systems revive existing scanner fleets with faster throughput, sharper image quality, and better patient experience – all without new hardware. The company will highlight their expansion into CT imaging, extending the same benefits across three modalities.

In addition, Subtle will also showcase the company’s vision for their new AI Imaging Hub: a unified agentic AI infrastructure that ingests multimodality data, accelerates and enhances imaging, and organizes outputs for downstream use—delivering more consistent studies, streamlined reading workflows, and actionable insights for radiologists and AI applications alike.  New products in production include AI-powered image quality checks, naming standardization, perfect image reformats, and a performance insights dashboard.

Attend Subtle Medical’s RSNA 2024 Events:

• Monday, Dec. 1 at 3pm: AI Theatre presentation by Subtle Medical (RSVP)
• Tuesday, Dec. 2 at 12pm: Lunch and Learn (RSVP required)

Partnerships Highlights

Bracco Imaging:  Co-developed with Subtle Medical, AiMIFY™ is the first and only AI program cleared by the FDA that selectively amplifies brain lesion MR image contrast. Using Subtle’s exclusive AI technology, the software increases lesion conspicuity in contrast-enhanced brain MRI, providing up to double the visibility of FDA-approved Gd doses.  It is now commercially available in the US, EU, and Brazil.  (Sold by Bracco)

Bayer Pharmaceuticals: Bayer and Subtle Medical recently announced positive findings from their POC clinical trial with SubtleGAD™, an AI-enabled algorithm aiming to synthesize full-dose contrast-enhanced images by enhancing contrast signals in MRI using a reduced contrast agent dose, with the goal to generate diagnostic-quality images. In 2025, they announced the decision to move forward with the next phase of the joint development. 

NVIDIA: Subtle will share its new vision-language foundation model for MRI data at RSNA, powered by NVIDIA. A member of the NVIDIA Inception program for startups, Subtle received early access to the NVIDIA Inception DG Cloud program with NVIDIA Brev clusters. The model was pretrained on ~500k scans in 23 hours using eight NVIDIA Hopper GPUs and cut fine-tuning on 50k labeled cases from 4.4h to 0.5h (~9× faster than the company’s internal stack), achieving >99% accuracy on around 1000 brain MRIs and >98% across 1500+ multi-anatomy cases—halving training times overall and accelerating innovation.

Strategic Radiology:  Subtle joined Strategic Radiology, a national coalition of independent, physician-owned radiology practices (47 groups, 2,200+ radiologists) united to keep radiology independent and elevate quality through collaboration and shared best practices. The Subtle portfolio is offered to members at a special rate.

Advantages of Subtle Medical’s AI-Powered Imaging Solutions:

• AI-Powered Image Acquisition: Accelerates the imaging process to serve more patients, with enhanced workflow efficiency while dramatically improving image quality for diagnostic confidence.
• Workflow Improvement Across All Scanners: Vendor-neutral software that improves image quality for both regular and accelerated protocols.
• Increased Efficiency and Capacity: Higher scan capacity and reduced wait times, enabling more patient throughput.
• Enhanced Patient Experience: Shorter exam times preferred by patients, especially those requiring repeat imaging.
• Extended Scanner Life: Virtually upgrades existing equipment to extend scanner usage without the need for new and expensive scanner upgrades and purchases.

Visit Subtle Medical at RSNA 2024

Subtle Medical invites all conference attendees to visit their Booth #4724 in the AI Showcase and schedule an onsite demo to experience these solutions firsthand. 

About Subtle Medical, Inc.

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World’s Top Healthcare Company (2025) and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company’s solutions are deployed on over 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improve image quality, and enhance patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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Anna Menyhart-Borroni

Head of Marketing

anna@subtlemedical.com

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AI-powered MRI enhancement now available to UK providers to improve scan speed, image quality, and operational efficiency

MENLO PARK, Calif., [Nov. 4, 2025] Subtle Medical, the market leader in AI-powered image acceleration and enhancement, today announced that it has received EU MDR CE Marking and successfully registered to enter the United Kingdom market. With this milestone, SubtleHD™ is now commercially available across the UK.

UK imaging services continue to face growing demand and resource pressures.  SubtleHD helps imaging teams boost efficiency and image quality through a vendor-neutral software solution that deploys easily with existing scanners, optimising performance and reducing wait times without additional hardware.

SubtleHD™ uses deep learning to enhance MRI image quality beyond standard of care and accelerate up to 80% faster scan acquisition, helping radiology providers reduce MRI backlogs, increase usage on currently operating magnets, and improve the patient experience with shorter scan times. As a vendor-neutral software, SubtleHD integrates seamlessly into current workflows and extends the life and performance of existing MRI scanners, a significant advantage in markets where access to new imaging equipment may be limited.

“Our entry into the UK market marks an exciting step in Subtle Medical’s global growth,” said Josh Gurewitz, Chief Commercial Officer of Subtle Medical. “We’re proud to bring SubtleHD’s proven technology to more radiology departments and imaging providers, helping them achieve higher-quality imaging and more efficient operations through AI innovation.”

Subtle Medical’s AI solutions for MRI and PET are currently deployed in over one thousand hospitals and imaging centers worldwide, supporting radiology teams in improving image quality, accelerating scans, and optimizing patient care.  To book a demo and learn more, schedule a meeting or visit Booth #4724 at RSNA 2025, AI Showcase, Level 3 or email sales@subtlemedical.com.

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World’s Top Healthcare Company (2025) and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company’s solutions are deployed on over 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improve image quality, and enhance patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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Anna Menyhart-Borroni

Head of Global Marketing

anna@subtlemedical.com

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MENLO PARK, Calif., Oct. 21, 2025 — Subtle Medical, Inc., a leader in AI-powered medical imaging solutions, today announced positive findings from a proof-of-concept (POC) study with Bayer, a leader in Radiology, evaluating Subtle Medical’s investigational SubtleGAD™ technology.

The study, including 39 patients undergoing imaging of the brain, conducted across five leading U.S. sites including Mayo Clinic, MD Anderson Cancer Center, OSF St. Francis Hospital Peoria, University of Massachusetts and The Pennsylvania State University, investigated SubtleGAD™, an AI-enabled algorithm aiming to synthesize full-dose contrast-enhanced images by enhancing contrast signals in MRI using a reduced contrast agent dose, with the goal to generate diagnostic-quality images.

In the study, patients received one of two investigational reduced doses of a gadolinium-based contrast agent after an initial full-dose baseline exam. Using Subtle Medical’s deep learning algorithm, synthesized full dose MR images from the reduced-dose acquisitions were compared with the standard-dose images.

Findings suggested similarity of the investigational AI-synthesized reduced-dose images when comparing lesion visualization parameter scores—contrast enhancement, border delineation, and internal morphology—with those of standard full-dose images.

“This study represents an important step forward in validating SubtleGAD™ as a tool to enable reduced gadolinium dose imaging without compromising quality,” said Dr. Ajit Shankaranarayanan, Chief Product Officer at Subtle Medical. “For patients, this may mean reduced exposure; for radiologists, it may offer confidence that diagnostic information is preserved with less gadolinium dose. We’re proud to collaborate with Bayer on this work, which underscores our shared commitment to advancing patient-centered innovation.”

Bayer has elected to extend its collaboration with Subtle Medical into the next phase of clinical development for SubtleGAD™. The partners will now focus on conducting further clinical research to evaluate the use of SubtleGAD, potentially supporting the use of reduced gadolinium dose milestones.

The collaboration builds on Subtle Medical’s growing portfolio of AI-powered image enhancement solutions, including FDA-cleared and CE-marked Subtle-ELITE™ (a comprehensive MRI package that includes three products:  SubtleHD™, SubtleSYNTH™ and SubtleALIGN™) and SubtlePET™.  Subtle’s AI solutions are deployed on over 1000 scanners worldwide. Together with Bayer’s leadership in contrast media, this partnership reflects the industry’s commitment to solutions that lower the contrast agent dose while focusing on patient safety, image quality, and imaging efficiency.

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized by TIME as a World’s Top Healthcare Company (2025) and multiple times as a CB Insights GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through responsible and intelligent software. The company’s solutions are deployed on over 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improved image quality, and better patient care without the need for new hardware. Learn more at www.subtlemedical.com.

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Anna Menyhart-Borroni

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MENLO PARK, Calif., Oct. 1, 2025 — Subtle Medical, a global leader in AI-powered medical imaging, today announced major growth milestones, projecting 2.5x annualized revenue growth in the U.S. for 2025, fueled by strong enterprise demand and new product introductions. Their U.S. adoption now spans more than 600 installations and well over 1000 globally.

Subtle continues to lead the AI imaging enhancement market, with multiple FDA-cleared solutions and the broadest install base among competitors. Its flagship SubtleHD™ software and newly launched Subtle-ELITE™ suite are enabling health systems to accelerate scans, improve image quality, and optimize workflow efficiency.

Last week, TIME recognized Subtle Medical on its list of the World’s Top HealthTech Companies of 2025, highlighting the company’s impact in AI and data-driven innovation for imaging.  Leading providers are deepening their enterprise-level partnerships with Subtle, citing measurable ROI and improved patient care.

“Subtle’s technology delivers value across our MRI operations.  As such, RadNet is able to accelerate scans while maintaining diagnostic confidence and reducing patient burden. The collaboration ensures our patients and physicians benefit from some of the best innovations in the field,” said Steven Forthuber, President & Chief Operating Officer, Eastern Operations, RadNet.

“SimonMed’s selection of Subtle as a collaboration partner pushes forth our mission to advance precision diagnostic imaging with AI, to improve the patient MRI experience and to allow us to continue to provide AI-enhanced care in an affordable and accessible way,” said John Simon, MD, Founder & CEO, SimonMed Imaging.

“Subtle’s technology is already delivering value across our MRI operations,” said Jin Kim, MD, CEO of Rezolut. “It enables us to accelerate scans while maintaining diagnostic confidence, reducing patient burden, and improving overall image quality. We are excited to expand our use of this innovative technology across our centers.”

The company’s expansion is fueled by recent FDA clearances, OEM partnerships, and enterprise customer expansions. Solutions such as SubtleSYNTH™, the only FDA-cleared AI solution for synthetic imaging, and AiMIFY™, a first-of-its-kind AI solution for enhanced contrast developed with Bracco, extend Subtle’s portfolio across MR, PET, and CT.

“Subtle’s growth trajectory demonstrates both the strength of our technology and the trust our customers place in us,” said Enhao Gong, PhD, Cofounder & CEO of Subtle Medical. “We are proud to lead the industry in building AI that accelerates, enhances, and organizes imaging data across modalities to deliver better care at scale.”

Validated results from Subtle customers includes the ability to:

• Enhance up to 80% faster scans and 50%+ higher throughput
  
  
• Improve diagnostic confidence through enhanced image quality
  
  
• Increase scanner utilization and extend equipment lifespan
  
  
• Achieve SaaS scalability across large imaging networks
  
  

With record adoption, validated ROI, and unmatched regulatory clearances, Subtle Medical is advancing its multi-modal strategy to further accelerate, enhance, and organize imaging data. Its mission remains clear: to empower healthcare providers with scalable AI solutions that improve quality, efficiency, and patient outcomes worldwide. Meet with us at RSNA 2025.

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scanner efficiency and image quality across radiology. Recognized by TIME on its World’s Top HealthTech Companies of 2025 list and multiple times by CB Insights as a GenAI 50, Digital Health 150, and Top AI 100 company, Subtle Medical is committed to transforming medical imaging through intelligent software solutions. The company’s products are deployed on over 1000 scanners worldwide, helping imaging centers and hospitals deliver faster scans, improved image quality, and better patient care, without the need for new hardware. Learn more at www.subtlemedical.com.

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Anna Menyhart-Borroni

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TIME Honors Subtle Medical for Advancing AI-Powered Solutions that Deliver Faster, Higher-Quality Medical Imaging

Menlo Park, Calif. – September 24, 2025 — Subtle Medical, a global leader in artificial intelligence (AI) solutions for medical imaging, today announced it has been recognized by TIME and Statista as one of the World’s Top HealthTech Companies 2025.

The inaugural list highlights companies worldwide that are transforming healthcare through innovation, impact, and digital engagement. Rankings were based on three categories: financial performance, reputation analysis, and online engagement.

Subtle Medical earned its place on the list for its groundbreaking portfolio of AI-powered imaging solutions, including:

• Subtle-ELITE™ Package (SubtleHD, SubtleSYNTH, and SubtleALIGN) – A suite of deep learning technologies that improves MRI image quality, accelerates exam times, and reduces manual tasks, enabling providers to deliver sharper images and more efficient workflows while extending the life of existing scanners.
  
  
• SubtlePET™ – AI software that improves PET image quality and allows for faster and lower dose PET scans, supporting safer, more comfortable patient experiences without compromising diagnostic accuracy.

Together, these solutions are helping hospitals and imaging centers worldwide achieve faster, higher-quality imaging without requiring new hardware investments.

“As a clinical neuroradiologist, I see firsthand the impact SubtleHD has on patient care. The technology delivers sharper, higher-quality images from faster scans, which directly improves diagnostic confidence in complex neurological cases. Most importantly, it allows us to provide safer, more efficient, and more patient-friendly imaging workflow without compromising accuracy—setting a new standard for how we care for patients every day.” — Suzie Bash, MD, Clinical Neuroradiologist and a Medical Director at RadNet

“Being named among TIME’s World’s Top HealthTech Companies is an incredible honor and a validation of our mission,” said Greg Zaharchuk, MD, PhD, Co-Founder of Subtle Medical. “Our AI solutions like SubtleHD and SubtlePET are making a measurable difference for patients, providers, and health systems every day. This recognition reinforces our commitment to advancing medical imaging efficiency and quality across the globe.”

The recognition by TIME and Statista further solidifies Subtle Medical’s position as a leading innovator in healthcare AI and underscores the urgent global need for solutions that expand imaging access, improve diagnostic confidence, and optimize clinical workflows. The award list can be viewed on Time.com.

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions that improve image quality and efficiency across radiology. Recognized as a CB Insights GenAI 50 company and multiple-time honoree on the CB Insights AI 100 and Digital Health 150 lists, Subtle Medical’s technologies are deployed on over 900 scanners in top hospitals and imaging centers worldwide. Its flagship products, SubtleHD™ and SubtlePET™, deliver faster scans, improved image quality, and enhanced patient outcomes—extending the life of existing imaging systems without requiring costly new hardware. Learn more at www.subtlemedical.com.

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Menlo Park, CA [Aug 13, 2025] — Subtle Medical, a global leader in AI-powered medical imaging software, today announced SubtleHD™ obtained ANVISA regulatory approval and is now commercially available in Brazil, marking a significant milestone in expanding access to advanced imaging enhancements across Latin America. The company has partnered with Hospiline, a trusted regional distributor supporting Subtle Medical’s growth throughout Brazil.

SubtleHD™, an FDA-cleared and CE-marked deep learning technology, enhances MRI image quality and delivers up to 80% faster scan times in some sequences. Seamlessly integrating into existing workflows, it extends the life and performance of current MRI scanners—critical in Brazil, where imaging infrastructure lags behind global benchmarks.

In Brazil, there are approximately 14.5 MRI units per million people—just below the global average of 20.7—despite rising demand for imaging services. National estimates indicate the need for 30,000 MRI exams per million inhabitants annually, translating to about 6 million MRI scans per year across Brazil’s 2,349 MRI systems  .

As patient volumes increase, public institutions often face long wait times, and many providers contend with aging equipment and tight budgets. SubtleHD™ empowers imaging providers to unlock additional scan slots without the need for new hardware, boosting operational efficiency and patient throughput. Brazilian healthcare institutions can now benefit from:

• Improved image quality, even on older MRI systems
  
  
• Faster exam times, helping to reduce patient backlogs
  
  
• Vendor-neutral compatibility with existing infrastructure
  
  

“We’re excited to introduce SubtleHD™ in Brazil,” said Josh Gurewitz, Chief Commercial Officer at Subtle Medical. “With Hospiline’s support, imaging providers across the country can now harness AI to bridge infrastructure gaps, elevate diagnostic confidence, and improve productivity—all while enhancing patient care.”

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and twice named among the CB Insights Top AI 100 and Digital Health 150, Subtle Medical is dedicated to innovation in medical imaging. Deployed globally across 900+ scanners, our solutions help imaging centers and hospitals improve workflow efficiency, enhance scanner longevity, and elevate patient outcomes. Learn more and request a demo at www.subtlemedical.com.

About Hospiline

Hospiline is a trusted distributor of advanced medical technologies throughout Latin America, committed to delivering innovative solutions that elevate patient care and clinical performance. Partnering with leading healthcare innovators, Hospiline brings modern, effective technologies to hospitals, clinics, and imaging centers across the region, supporting and optimizing the healthcare ecosystem.

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The certification reinforces the company’s leadership in AI safety, efficacy, and ethical governance.

MENLO PARK, Calif. – July 30, 2025 – Subtle Medical, a global leader in AI-powered medical imaging software, announced it has earned one of the first accredited ISO/IEC 42001:2023 certifications for its AI Management System. This milestone reflects Subtle Medical’s leadership in developing safe, effective, and ethically governed AI solutions in medical imaging.

ISO/IEC 42001 is the world’s first international standard specifically focused on the management of artificial intelligence. Achieving this certification signals that Subtle Medical has implemented a robust and auditable system for overseeing the responsible use of AI—addressing key requirements around transparency, fairness, explainability, robustness, and security.

“As the regulatory landscape evolves rapidly in response to AI innovation, Subtle Medical remains committed to the highest standards in patient safety and product quality,” said Ajit Shankaranarayanan, PhD, Chief Product Officer. “This certification provides independent validation of our AI development processes and confirms we are ahead of the curve.”

The certification has already proven relevant to Subtle Medical’s commercial operations.

“Customers are increasingly asking vendors to prove how they govern AI,” said Ben Wright, Head of IT and Cybersecurity. “We’ve seen AI-related questions added to supplier evaluations, and I’ve personally engaged with AI governance boards at several customer organizations. This certification confirms we’re aligned with the best practices.”

Benefits of ISO/IEC 42001 Certification Include:

• Patient Safety: Ensures Subtle Medical’s management system supports a fair, secure and clinically robust AI life cycle. 
• Customer Confidence: Demonstrates that Subtle’s AI governance meets global standards.  
• Risk Mitigation: Prioritizes proactive risk management across AI development and deployment.
• Operational Excellence: Integrates quality practices across the product lifecycle for continuous improvement.
  

Subtle Medical’s path to certification accelerated when it was selected by Intertek, a leading Total Quality Assurance provider to industries worldwide, for its accreditation witness audit. The company’s readiness was the result of years of internal alignment with evolving FDA guidance and rigorous quality standards.

“Between every FDA submission, we refine our processes to reflect the latest regulatory expectations,” said Ronny Elor, Head of Quality Engineering and Regulatory Affairs. “By the time we began ISO 42001 preparations, we found that much of our system already met the criteria. It was rewarding to formalize what we’ve already built.”

Looking ahead, the certification will support Subtle Medical’s continued growth and innovation. Visit their Compliance page for more information or book a demo to learn more about AI software solutions for faster and higher quality medical imaging. 

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical’s solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care.  Learn more and request a demo at www.subtlemedical.com.

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Menlo Park, CA [May 29, 2025] — Subtle Medical, a global leader in AI-powered medical imaging software, announced today the commercial availability of SubtleHD™ in Chile, marking an important step in expanding access to advanced imaging solutions across Latin America. The company also confirmed it will partner with Hospiline, a trusted regional distributor that currently supports Subtle Medical’s growth in Brazil.

SubtleHD™ is an FDA-cleared and CE-marked deep learning technology that transforms the quality of MRI images and enables up to 80% time savings on some sequences. It integrates seamlessly into existing clinical workflows, extending the life and performance of existing MRI scanners, an especially critical need across Latin America, where aging imaging infrastructure is common.

In Brazil, for example, over 66% of MRI scanners are more than six years old, while demand for MRI exams is growing rapidly, estimated at 30,000 scans per million inhabitants per year. As patient volumes rise, public institutions often face long wait times, and many providers are challenged to meet demand with outdated equipment.

SubtleHD helps imaging providers unlock new scan slots without purchasing new hardware, improving operational efficiency and patient throughput. With SubtleHD, healthcare institutions in Chile can now benefit from:

• Improved image quality even on older MRI systems
  
• Faster exam times, helping reduce patient backlog
  
• Vendor-neutral compatibility with existing infrastructure
  

“We’re thrilled to expand access to SubtleHD in Chile,” said Josh Gurewitz, Chief Commercial Officer, at Subtle Medical. “With the support of Hospiline, imaging providers across the region can now harness AI to overcome infrastructure gaps, boost productivity, and elevate diagnostic confidence.”

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical’s solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care. Learn more and request a demo at www.subtlemedical.com.

About Hospiline

Hospiline is a trusted distributor of advanced medical technologies across Latin America, committed to delivering innovative solutions that elevate patient care and clinical performance. United by a vision of excellence, we partner with leading global healthcare innovators to bring the most modern, effective technologies to hospitals, clinics, and imaging centers throughout the region. Our mission is to support and optimize the healthcare ecosystem by ensuring access to cutting-edge medical products that enhance outcomes and drive operational efficiency.

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