Leveraging AI’s emergence in enhancing medical imaging to revolutionize diagnostics

The medical imaging industry is undergoing a dynamic phase of growth and innovation, with its global market value reaching approximately USD 40 billion in 2022 and an anticipated expansion at a Compound Annual Growth Rate (CAGR) of about 5.5% through 2032. This surge is primarily fueled by continuous advancements in medical imaging technologies, which are essential for the early detection and precise diagnosis of various health conditions, thereby facilitating prompt and effective treatment.

Within this burgeoning market, different segments are evolving at varied paces. The ultrasound sector, for example, held the majority of the market share in 2022. It is expected to continue leading, thanks to an increase in ultrasound applications and advancements in ultrasound transducer technology. Artificial intelligence’s integration into ultrasound systems is further propelling this segment’s growth. On the other hand, the Computed Tomography (CT) segment is predicted to experience the most rapid growth. This is largely due to the soaring demand for point-of-care CT devices and the development of AI and Machine Learning-integrated high-precision CT scanners.

The end-use landscape of the market is also witnessing shifts. Hospitals accounted for the largest market portion in 2022, driven by a growing demand for advanced imaging technologies and the integration of these technologies into surgical suites. This demand is particularly pronounced in developed regions, where teaching hospitals are increasingly adopting advanced imaging modalities. Additionally, diagnostic imaging centers are witnessing substantial growth, bolstered by the adoption of cutting-edge technologies and infrastructure enhancements.

Geographically, North America was the dominant force in the market in 2022, a position it secured through the presence of numerous industry players and frequent new product launches. The region’s robust adoption of high-end medical imaging equipment is supported by favorable reimbursement policies and significant healthcare expenditures. In contrast, the Asia-Pacific region is projected to experience the fastest growth in the medical imaging market. This growth is driven by an increase in chronic disease incidences and a high demand for advanced imaging devices, coupled with the rise of local manufacturing units providing cost-effective diagnostic equipment, which is especially beneficial in this price-sensitive market.

Amidst this evolving landscape, Subtle Medical, established on August 1, 2017, by Enhao Gong and Greg Zaharchuk, has emerged as a noteworthy player. The company’s roots are intertwined with Stanford University, which significantly influenced both founders’ professional paths and the genesis of Subtle Medical. Headquartered in Menlo Park, California, Subtle Medical is focused on leveraging its expertise to further revolutionize the medical field. The company’s mission is to deliver medical imaging solutions that are faster, more cost-effective, and smarter, ultimately benefiting patients and healthcare facilities worldwide.

Pain point addressed

Subtle Medical, a pioneering company in the medical imaging sector, zeroes in on specific challenges within MRI and PET scans, offering innovative solutions that impact various stakeholders in healthcare. Its technology notably shortens the duration of these scans, which traditionally take 30 minutes to an hour, thereby enhancing patient comfort and enabling healthcare facilities to increase their imaging throughput. This is particularly advantageous in high-demand regions, streamlining the imaging process and improving patient care efficiency.

Additionally, Subtle Medical addresses the safety concerns associated with the use of gadolinium-based contrast agents in MRI scans. Their technology reduces the need for these agents, mitigating potential health risks, especially for patients with kidney issues. The stakeholders benefiting from Subtle Medical’s advancements include patients, who experience more comfortable and safer scans; healthcare professionals, who see increased operational efficiency; and healthcare facilities, which can potentially lower costs and serve more patients. This innovation is globally relevant but especially critical in areas with high patient volumes and limited imaging resources.

Type of solution

Subtle Medical offers a hybrid solution that combines software with existing hardware in the medical imaging field. Their products, such as SubtlePET™ and SubtleMR™, are deep-learning-powered image enhancement software solutions. These AI-based tools are designed to improve the quality of images captured from both accelerated and low-dose scans and are compatible with all scanner brands and models.

SubtlePET™ specifically denoises scans conducted in a fraction of the original scan duration, while SubtleMR™ utilizes denoising and increased resolution to enhance the quality of suboptimal scans. This means that healthcare centers can optimize scan times without compromising image quality. Additionally, their investigational product SubtleGAD™ is aimed at reducing the necessary dose of Gadolinium, a contrast agent used in MRI, by up to 90% while maintaining high-quality MRI images.

Subtle Medical’s solutions are a prime example of how AI can be integrated into existing medical imaging hardware to enhance efficiency and safety in diagnostic procedures. This approach represents a significant advancement in the medical imaging industry, allowing for faster, safer, and smarter imaging processes.

Type of input data leveraged

Subtle Medical’s AI-powered medical imaging solutions utilize a variety of input data types, including:

• MRI scans: Utilizes high-resolution images from MRI scanners for quality enhancement in SubtleMR™.
• PET scans: Employs data from PET scans in SubtlePET™ for image denoising and clarity improvement.
• Contrast-enhanced images: Uses images from contrast-enhanced MRI scans for their research product SubtleGAD™, which involves gadolinium-based contrast agents.
• Standard diagnostic images: Processes images from a range of standard diagnostic procedures across diverse scanner brands and models.
• Accelerated scan data: Handles data from accelerated scan processes to maintain image quality in shortened scan times.
• Low-dose scan data: Focuses on processing low-dose imaging data, particularly critical for radiation-sensitive scans, to enhance image quality without increasing radiation exposure.

Key technology involved

Subtle Medical’s innovative approach in medical imaging enhancement is built on several key technological pillars, each contributing uniquely to their advanced AI-powered solutions:

• Deep learning: Central to Subtle Medical’s technology stack, deep learning algorithms are adept at analyzing and enhancing complex medical imaging data. This technology is particularly vital in SubtlePET™ and SubtleMR™, where it is employed for sophisticated image processing. These algorithms are capable of discerning subtle patterns and variations in imaging data, which are then used to significantly improve image quality, offering clear and precise imaging essential for accurate diagnoses.
• Artificial intelligence (AI): AI plays a crucial role in enhancing and refining medical imaging. In Subtle Medical’s products, AI algorithms are specifically designed to improve denoising, enhance image resolution, and reduce scan times without compromising the quality of the images. This technology ensures that even with accelerated scan processes, the integrity and clarity of medical images are not sacrificed, thus maintaining the standard of care in medical diagnostics.
• Image processing algorithms: Specialized image processing algorithms are employed by Subtle Medical to enhance the quality of medical images. These algorithms are particularly effective in restoring and optimizing image quality from scans that are either accelerated or have a low dose. The ability to process and enhance images from various scan types allows for greater flexibility and adaptability in clinical settings.
• Data analytics: Data analytics tools are integral to Subtle Medical’s approach. They process vast amounts of imaging data, extracting valuable insights and optimizing the performance of AI models. This aspect of technology is crucial for handling and interpreting the large datasets typical in medical imaging, ensuring that the AI models are continually learning and improving.
• Cloud computing: Cloud computing provides Subtle Medical with the necessary scalable processing power to handle large volumes of medical imaging data. This technology is essential for efficient data management and processing, allowing for the rapid analysis of complex imaging datasets without the need for extensive on-premises hardware.
• Scanner interoperability: A key feature of Subtle Medical’s solutions is their compatibility with a wide range of medical imaging scanners. This interoperability ensures that their AI-powered solutions can be integrated seamlessly into various healthcare settings, making them versatile and widely applicable across different imaging modalities and equipment brands.

Key applications of solution

Diagnostic imaging enhancement

Subtle Medical is revolutionizing the field of diagnostic imaging through its cutting-edge AI-powered solutions, SubtleMR™ and SubtlePET™, which are transforming the way MRI and PET scans are conducted and interpreted.

• SubtleMR™: This technology is a game-changer in MRI imaging. It leverages advanced AI algorithms to significantly enhance the quality of MRI images. This innovation is particularly crucial for scans that are suboptimal due to various factors like patient movement or technical limitations. By improving image quality, SubtleMR™ finds extensive use in diverse MRI applications, including neurological, musculoskeletal, and body imaging. This advancement is pivotal in ensuring that clinicians receive the clearest possible images for accurate diagnosis, thereby enhancing patient care.
• SubtlePET™: In the realm of PET scans, SubtlePET™ employs sophisticated deep learning techniques for denoising scans. This innovation ensures enhanced image clarity without the need to extend scan times, a critical factor in patient comfort and operational efficiency. SubtlePET™ is particularly beneficial in fields like oncology, neurology, and cardiology, where PET scans play a crucial role in diagnosis and monitoring of diseases.

Reduced exposure to contrast agents

• An important area of Subtle Medical’s research is the development of SubtleGAD™. This technology is focused on reducing the use of Gadolinium in MRI scans. Gadolinium, a contrast agent, although useful, poses risks, particularly for patients with renal impairments. SubtleGAD™ aims to reduce the necessary dosage of Gadolinium by up to 90% while still maintaining the high quality of MRI images. This innovation is a significant step towards safer MRI scans, reducing the potential health risks associated with contrast agents.

Accelerated imaging procedures

• Across its suite of solutions, Subtle Medical is also addressing the need for faster imaging procedures without compromising image quality. Both SubtleMR™ and SubtlePET™ enable faster scanning protocols, which is a boon in high-volume clinical settings and emergencies where time is of the essence. Faster scans not only improve patient throughput in busy medical settings but also enhance the patient experience by reducing the time spent in scanners.

Implications for key stakeholders

• Patients

Beyond the obvious comfort of shorter scan times, patients benefit from Subtle Medical’s technology in more nuanced ways. For example, patients with anxiety or claustrophobia can experience less stress due to reduced time on MRI machines. Additionally, patients with renal impairments who are at risk from Gadolinium-based contrast agents can undergo MRI scans with reduced apprehension due to SubtleGAD™, which aims to minimize the contrast dosage required.

• Radiologists

Radiologists can interpret images with greater confidence, thanks to the enhanced image clarity provided by SubtleMR™ and SubtlePET™. This is particularly impactful in complex cases where high-quality imaging can be the difference between an accurate diagnosis and a missed one. For instance, in neurology, where precise imaging is crucial for identifying brain anomalies, the improved clarity of scans can significantly aid in diagnosis and treatment planning.

• Healthcare facilities

Hospitals and imaging centers gain from increased throughput due to faster scans, translating to better resource utilization and potentially higher revenue. A tangible example is a busy hospital where MRI and PET scan backlogs can be significantly reduced, leading to more efficient patient scheduling and decreased wait times for critical diagnostic procedures.

• Insurers

With the efficiency brought by Subtle Medical’s solutions, there is a potential for cost savings in the long run. For instance, by reducing the number of repeat scans due to poor image quality and minimizing the use of expensive contrast agents, healthcare payers can see a decrease in the overall cost per patient imaging procedure.

• Regulatory bodies

These agencies ensure that products like SubtlePET™ and SubtleMR™ meet stringent safety and performance standards. They oversee clinical trials for ethical and scientific rigor and enforce data privacy and security regulations, crucial for AI technologies handling patient data. Post-market surveillance by these bodies also guarantees ongoing safety and efficacy, maintaining high standards in healthcare technology. This regulatory oversight is vital for the safe and effective integration of such innovative technologies in clinical settings.

Current impact

• Global expansion: Subtle Medical has experienced impressive growth, doubling its business both in the US and internationally. This expansion reflects the increasing demand for AI solutions in faster medical imaging and better patient care. The company’s technology has been embraced across diverse regions, including Europe, South America, Canada, and the Asia-Pacific.
• Vendor-agnostic technology: Their solutions work with any brand of PET and MRI scanner. This versatility enables healthcare systems to optimize imaging operations dramatically, reducing scan times and improving performance. This feature translates to increased productivity for healthcare institutions and a better patient experience.
• Product innovation: Subtle Medical’s product portfolio includes SubtlePET™ and SubtleMR™, which are FDA-cleared and CE-marked, and have been commercially deployed in over 400 sites worldwide. SubtlePET™ and SubtleMR™ use deep learning to improve the image quality of accelerated MRI and PET scans, boosting exam throughput and profitability. Subtle Medical continues to innovate with products like SubtleSYNTH™, which synthesizes MRI contrast from already acquired contrasts, enabling a 100% acceleration in scan times.

Potential future impact

• Subtle Medical is poised to continue its trajectory of rapid growth and innovation in AI-powered medical imaging. With the company already doubling its business globally and expanding into new territories, it’s clear that Subtle Medical plans to further deepen its international presence. Their focus on vendor-agnostic technology indicates a potential for broader application in various healthcare systems, optimizing imaging operations across different brands of PET and MRI scanners.
• Subtle Medical’s ongoing research, like the development of SubtleGAD™ and SubtleSYNTH™, points towards a future where medical imaging is not only faster but also safer, reducing the use of contrast agents and accelerating scan times without sacrificing image quality. The company’s efforts in forming strategic partnerships and collaborations suggest a future where Subtle Medical’s technology becomes integral to the medical imaging sector globally.
• With Subtle Medical’s expertise in AI and deep learning for medical imaging, there is potential for expansion into other areas of diagnostic imaging and treatment planning. For instance, they could consider extending their AI algorithms to areas like digital pathology, where AI can play a significant role in analyzing complex pathological data. Another potential avenue could be in personalized medicine, where AI technology could be used to tailor imaging protocols to individual patients’ needs, enhancing the precision of diagnostics.
• There is scope for integrating their technology with telemedicine platforms, providing remote diagnostics capabilities, which could be particularly transformative in regions with limited access to advanced medical imaging facilities.

Business model

Subtle Medical primarily operates in a B2B framework, selling its AI-powered imaging solutions directly to healthcare providers, such as hospitals and diagnostic centers. This model allows the company to leverage the existing infrastructure of these institutions, facilitating the integration of its technology into their workflow.

Advantage

• The advantage of this approach is the ability to form long-term partnerships with healthcare providers, ensuring a steady revenue stream and opportunities for continuous feedback and improvement of their products. For example, partnerships with large hospital networks could lead to widespread adoption of their technology, significantly increasing their market presence.

Funding and key investors

Subtle Medical has successfully secured $49.2 million through eight funding rounds, with the most recent influx of capital coming from a grant received on September 13, 2023. This steady financial backing underscores the company’s robust growth trajectory and the confidence of investors in its innovative medical imaging technology.

Subtle Medical’s key investors include notable entities such as the National Institutes of Health, SAV (Scale Asia Ventures), Crista Galli Ventures, Fusion Fund, 3E Bioventures, and Delta Capital. These investors have played a significant role in different funding rounds, with the National Institutes of Health notably leading grant rounds and entities like SAV, Crista Galli Ventures, Fusion Fund, 3E Bioventures, and Delta Capital contributing to Series A and Series B rounds.

Competitive differentiator

• Subtle Medical’s competitive differentiator lies in its unique approach to enhancing the efficiency of medical imaging without the need for additional hardware. Subtle Medical zeroes in on the nuanced aspect of optimizing existing imaging equipment.
• They employ AI-driven software to not only accelerate imaging processes but also improve image quality from scans taken with a reduced dosage of contrast agents or in shorter time frames.
• This focus on software-based optimization of existing hardware sets them apart in the medical imaging field, providing a cost-effective and easily integrable solution for healthcare providers.
• This specific approach addresses a crucial gap in the market, enhancing the capabilities of already-installed imaging equipment without the significant expenses and logistical challenges associated with acquiring new hardware.

Relevant regulatory and compliance requirements

• FDA approval (U.S. Food and Drug Administration): For any medical device or software to be used in the U.S., FDA approval is necessary. This ensures the solution meets safety and efficacy standards.
• CE marking (European Conformity): In the European Union, CE marking is required, indicating compliance with health, safety, and environmental protection standards.
• HIPAA compliance (Health Insurance Portability and Accountability Act): This U.S. legislation provides data privacy and security provisions for safeguarding medical information, critical for any healthcare-related technology handling patient data.
• GDPR compliance (General Data Protection Regulation): In the EU, GDPR sets standards for data protection and privacy, including for health data, making it essential for medical imaging solutions offered in Europe.
• ISO certifications: International Standards Organization certifications, like ISO 13485 for medical devices, which set quality management system standards, are important for global operations.

Partnerships and collaborations

• Incepto partnership: Subtle Medical expanded its partnership with Incepto, a leading AI platform for radiology professionals in Europe. This collaboration involves offering Subtle Medical’s AI applications, SubtleMR™ and SubtlePET™, on Incepto’s platform. This partnership allows Incepto’s customer base to access Subtle Medical’s AI solutions, enhancing workflow and patient comfort in the radiology sector.
• Collaboration with Bayer: Subtle Medical collaborated with Bayer to advance deep learning research in medical imaging. This partnership focuses on exploring the potential of Subtle Medical’s AI algorithm, SubtleGAD™, for use in contrast-enhanced MRI exams. The goal is to enhance image quality and investigate new areas for contrast media use, combining Bayer’s expertise in healthcare and nutrition with Subtle Medical’s AI technology.
• Cortechs.ai distribution partnership: Subtle Medical joined forces with Cortechs.ai, a leader in radiology AI applications. This non-exclusive business development agreement expands the reach of Subtle Medical’s automated image reconstruction solutions globally. SubtleMR™ and SubtlePET™ complement Cortechs.ai‘s portfolio, integrating seamlessly with any PET or MRI scanner and PACS to enhance images without altering existing workflows. This partnership is significant for improving radiology efficiency and clinical findings.

Testimonials and case studies

“With Subtle Medical, we were able to achieve the same high quality images with a 33% reduction in FDG dose. This had a positive impact on patient safety and the operational workflow too. Following the successful pilot in Italy, we decided to deploy the innovative solution across Affidea Europe, where we have an extensive volume of PET/CT units.” Alessandro Roncacci, MD Chief Medical Officer, Affidea (Torino, Italy)

“PET/CT practice in Paris is very competitive as there are only about 45 systems. It’s very important for us at CCN to minimize the wait time delay for a PET appointment and ensure the best possible experience for patients during their procedure What’s appealing to us about SubtlePET™ is that the technology allows us to reduce the wait times and time spent in the scanner, while providing high quality diagnostic images.” Gerald Bonardel, MD Professor, Centre Cardiologique du Nord (CCN) Hospital Delafontaine (Paris, France)

Areas for continuous improvement

Subtle Medical could explore several avenues for continuous improvement in its AI-driven medical imaging technology:

• Enhancing AI adaptability and generalizability: Subtle Medical could enhance the adaptability and generalizability of its AI algorithms. This would enable the technology to effectively handle a diverse array of medical cases and patient variations, ensuring accurate diagnostics across various conditions and patient profiles. Such improvements could make the technology more versatile and efficacious for a wider range of patients.
• Integrating predictive analytics: The company could also integrate predictive analytics into its imaging solutions. By doing so, Subtle Medical’s technology could shift from merely enhancing image quality to aiding in early disease detection and prognosis. This integration would transform the technology into a comprehensive clinical decision support tool, providing valuable insights for patient care and treatment planning.
• Personalizing imaging protocols: Subtle Medical could further develop personalized imaging protocols. By tailoring scanning protocols to individual patient characteristics, the technology could optimize the safety and effectiveness of imaging procedures. This approach would consider factors like the patient’s age, medical history, and specific health conditions, providing a customized and more precise diagnostic experience.

References

https://subtlemedical.com/#

https://www.crunchbase.com/organization/subtle-medical/company_financials

Disclaimer: Please note that the opinions, content, and analysis in my posts are entirely my own and do not reflect the views of any current or past employers or institutional affiliations. These posts, based solely on publicly available information, are for informational purposes and should not be taken as professional advice. All insights and conclusions are my viewpoints and should not be considered representative of any organizations I am or have been associated with. This content is not endorsed by, nor does it represent the stance of any affiliated entity.