SubtlePET

by Subtle Medical  · Based in United States →AI-Powered Image Acquisition: Faster, Safer, Smarter Medical Imaging
Nuclear Medicine Oncology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

SubtlePET by Subtle Medical is an AI-powered image processing software designed to enhance the efficiency and quality of Positron Emission Tomography (PET) imaging. Leveraging proprietary deep learning algorithms, SubtlePET reduces noise in low-count PET scans, enabling significantly faster acquisition times—up to 75% faster—without compromising image quality or diagnostic accuracy. This technology acts as a virtual upgrade for existing PET and PET/CT scanners, integrating seamlessly into current radiology workflows. It supports a wide range of radiotracers, including 18F-FDG, 18F-amyloid, 18F-DOPA, 18F-Choline, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA, expanding its utility across various clinical applications such as oncology, neurology, and urology. By accelerating scan times, SubtlePET aims to improve patient comfort, increase scanner throughput, and optimize resource utilization for hospitals and imaging centers.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered image enhancement
  • Up to 75% faster PET imaging
  • Reduces imaging time without compromising image quality or diagnostic accuracy
  • Proprietary denoising algorithm for low count PET scans
  • Compatible with any scanner brand (vendor-neutral)
  • Supports multiple radiotracers (e.g., 18F-FDG, 18F-amyloid, Ga-68 PSMA)
  • Improves patient comfort by reducing scan time
  • Increases throughput and revenue for imaging facilities
  • Seamless integration into existing radiology workflows (DICOM compatible)
  • Potential for reduced injected radiotracer dose

Use Cases

  • Accelerating PET imaging procedures
  • Improving image quality of low count PET scans
  • Enhancing diagnostic accuracy and confidence
  • Increasing patient comfort and experience during scans
  • Optimizing workflow and resource utilization in imaging centers
  • Extending the lifespan and performance of existing PET scanner fleets

What Physicians Need to Know

Key Capabilities
AI-powered denoising algorithm for low count PET scans, enabling up to 75% faster imaging and/or lower radiotracer doses while maintaining image quality and diagnostic accuracy. It's compatible with any scanner brand and supports various radiotracers (e.g., 18F-FDG, 68Ga-PSMA-11).
Clinical Utility
Improves patient experience by reducing scan times, leading to less discomfort and anxiety. Increases patient throughput and scanner capacity, optimizing resource utilization and potentially increasing revenue. It also has the potential to reduce technologist radiation exposure.
Integration Options
Seamlessly integrates with any OEM scanner and Picture Archiving and Communication System (PACS), sitting between the scanner and PACS. It can be deployed in the cloud or on-premise and is compatible with all scanner brands and models. Partnerships exist with platforms like Aidoc and Incepto.
Compliance Status
FDA 510(k) cleared and CE Mark approved for marketing in the European Economic Area. The software is also HIPAA compliant and PHI safe.
Pricing Model
A value-based or subscription model, with studies indicating pricing can be an agreed percentage (e.g., 15-20%) of the radiopharmaceutical savings achieved per examination.
User Experience
Designed for seamless integration into existing clinical workflows with minimal changes. It's easy to deploy (under 24 hours) and enhances images within seconds. Patients report improved comfort and satisfaction due to shorter scan times.
Support Quality
Support, including free setup and training, is typically included as part of the subscription model, ensuring continuous operation and assistance.
Implementation Complexity
Considered quick and simple, with deployment often taking less than 24 hours and requiring little to no change in existing workflows. It integrates non-disruptively between the scanner and PACS.
Evidence Base
Supported by multiple peer-reviewed research studies and clinical validations published in top journals. Studies confirm its ability to enable shorter PET exams and/or lower doses without compromising image quality or diagnostic confidence across various radiotracers. It has been deployed in numerous university hospitals and imaging centers globally.
Physician Tip

SubtlePET offers a significant opportunity to enhance PET imaging efficiency and patient experience. Consider implementing this AI tool to reduce scan times, which can alleviate patient discomfort, especially for those who struggle to remain still. The ability to maintain diagnostic image quality with lower radiotracer doses also presents benefits for patient safety and resource optimization. Evaluate its impact on your facility's throughput and potential for increased patient volume.

SubtlePET is designed for broad compatibility, integrating seamlessly with existing PET scanners (regardless of brand or model) and PACS systems. Its 'in-line' processing between the scanner and PACS ensures minimal disruption to current workflows. Explore partnerships with AI platforms like Aidoc and Incepto for a more comprehensive AI ecosystem within your imaging department.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Contact for pricing Negotiated pricing available for Vizient members.
DeploymentSoftware as a Service (SaaS) or software systems deployed to hospitals and imaging centers, integrating with existing PACS and scanners.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images.

Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

SubtlePET, developed by Subtle Medical, is an AI-powered software designed to enhance PET image quality and accelerate scan times. It has received FDA 510(k) clearance and CE Mark approval, and is deployed on over 1,300 scanners worldwide. The technology aims to improve patient experience by reducing discomfort and anxiety associated with long scan times, while also boosting imaging center throughput and profitability.

Overall: Positive

Strengths

  • Enables significantly faster PET scan times (up to 75% reduction) without compromising image quality or diagnostic accuracy.
  • Improves image quality by denoising low-count PET images, making them comparable to standard, longer scans.
  • Increases patient comfort and satisfaction by reducing time spent in the scanner.
  • Boosts imaging center efficiency, throughput, and profitability by allowing more patients to be scanned daily.
  • Integrates seamlessly with existing OEM scanners and PACS systems without requiring hardware changes or altering workflow.
  • Supports a wide range of FDA-approved radiotracers and offers improved performance with new releases.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • Some general G2 and Capterra reviews for other products mention issues with customer service or review verification processes, but these are not specific to SubtlePET.
  • The value of Subtle Medical's products can be tied to scanner mix and protocols.
  • Pricing is sales-led and scoped per buyer rather than publicly posted.

Based on reviews from: SoftFinders, Elion, The Imaging Wire, G2, Subtle Medical Customer Testimonials, PR Newswire, AuntMinnie, Slashdot, YouTube, PubMed Central

Last updated: 2026-07-20

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Press & Coverage

PR Newswire
Subtle Medical Receives FDA Clearance for SubtleHDu2122(PET), Next-Generation AI-Powered Image Acceleration and Enhancement Software
Subtle Medical announced FDA clearance for SubtleHDu2122(PET), an AI-powered PET image enhancement solution that improves image quality and accelerates PET imaging workflows by up to 75% on existing PET/CT and PET/MR systems. This new solution supports all FDA-approved radiotracers and expands Subtle Medical's market reach.
2026-05
Imaging Technology News
FDA Clearance Granted to Subtle Medical's SubtleHDu2122(PET) for Improved Imaging
Subtle Medical has received FDA clearance for its AI-powered SubtleHDu2122(PET) software, designed to enhance PET imaging capabilities by improving image quality and accelerating scan processes across PET/CT and PET/MR systems. This clearance broadens Subtle Medical's presence in the PET market, especially for facilities using advanced radiotracers and theranostic programs.
2026-05
Fierce Biotech
AI-powered medical imaging startup Subtle Medical picks up $33M and taps new CEO
Subtle Medical secured $33 million in growth capital and appointed Ohad Arazi as its new CEO. The company's SubtlePET AI software improves PET image quality and enables faster, lower-dose PET scans, with its solutions deployed on over 1,300 scanners worldwide.
2026-06
PR Newswire
Telix Partners with Subtle Medical on AI-Enabled SubtlePETu2122 Software for Faster PET Imaging with Illuccixu00ae
Telix Pharmaceuticals announced a partnership with Subtle Medical to integrate AI-powered SubtlePETu2122 software for faster PET imaging with Telix's Illuccixu00ae product. SubtlePETu2122 is an FDA-cleared AI solution that allows for up to 75% time savings in PET scanning without compromising image quality.
2024-10
Journal of Imaging (via PMC)
Implantation of an Artificial Intelligence Denoising Algorithm Using SubtlePETu2122 with Various Radiotracers: 18F-FDG, 68Ga PSMA-11 and 18F-FDOPA, Impact on the Technologist Radiation Doses - PMC
This study found that SubtlePETu2122 consistently enhanced image quality across various radiotracers, allowing for reduced acquisition times and lower injected doses while maintaining diagnostic accuracy. It also demonstrated improved efficiency for medical facilities by increasing patient throughput and optimizing resource use.
2025-07
PR Newswire
Subtle Medical Showcasing AI-Powered SubtlePET Software for Faster PET Imaging at 2023 SNMMI Conference
Subtle Medical participated in the 2023 SNMMI conference, showcasing its SubtlePETu2122 software, which uses AI to enable up to 75% faster PET imaging. This technology aims to enhance patient comfort, increase medical facility revenue, and optimize resource utilization.
2023-06
Journal of Nuclear Medicine
SubtlePET Analysis Using American College of Radiology Phantom and Guidelines
This study evaluated SubtlePET using the American College of Radiology PET phantom and guidelines, concluding that SubtlePET with a shorter bedtime (78 seconds) can result in a lower patient dose and allow for more scheduled exams without compromising image quality compared to a 3-minute scan.
2022-08
PR Newswire
Subtle Medical Receives FDA 510(k) Clearance and CE Mark Approval for SubtlePETu2122
Subtle Medical announced it received 510(k) clearance from the U.S. FDA and CE Mark approval for SubtlePETu2122, making it the first AI product cleared for medical imaging enhancement. This clearance allows Subtle Medical to market SubtlePETu2122 in the U.S. and European Economic Area.
2018-12

Videos

Product demos, reviews, and walkthroughs for SubtlePET.

View all on YouTube

Frequently Asked Questions

SubtlePET is an AI-powered software solution that enhances images from faster and/or lower dose PET scans by utilizing deep learning algorithms for denoising. This technology allows for significant reductions in scan time, up to 75%, or lower radiotracer doses while maintaining or improving diagnostic image quality.
Yes, SubtlePET has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval for marketing in the European Economic Area. Subtle Medical, the developer, also emphasizes a compliance center and privacy policy, indicating adherence to relevant healthcare data security standards.
SubtlePET is designed for seamless integration into existing clinical workflows, operating as a vendor-neutral software solution between any OEM scanner and the Picture Archiving and Communication System (PACS). After images are acquired, they are enhanced by SubtlePET either in the cloud or on-premise, and then sent back to PACS for interpretation without altering the imaging specialists' normal workflow.
For patients, SubtlePET significantly reduces scan times, leading to improved comfort, less anxiety, and minimized discomfort, especially beneficial for those who struggle to remain still. For imaging centers, it boosts efficiency by increasing patient throughput, optimizing resource utilization, and potentially extending the life of existing scanners without requiring new capital expenditures.
While SubtlePET significantly improves image quality, a potential limitation of AI-based denoising techniques, including SubtlePET, is the possibility of 'over-smoothing,' which might lead to blurring or even the loss of subtle lesions. Studies have also suggested the benefit of future blinded inter-reader studies to mitigate potential bias in image evaluation.
Alternatives to SubtlePET include traditional PET image reconstruction methods, which often face limitations such as higher noise levels and longer acquisition times. Other AI solutions in medical imaging exist, like SubtleMR for MRI, but SubtlePET specifically targets PET image enhancement.
While specific pricing details are not widely disclosed, information suggests that SubtlePET may operate on a per-examination pricing model, with one study indicating an agreed price per examination equivalent to 15-20% of FDG savings. This implies a value-based or subscription-based approach rather than a large capital expenditure.

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

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