SmartTarget

by SmartTarget Ltd (now integrated into Focalyx Fusion by Intuitive Fusion LLC)  · Based in United States → — Precision prostate targeting
Interventional Radiology Radiology Urology
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Regulatory Status Disclosed

Overview

SmartTarget is an AI-powered image fusion software developed by SmartTarget Ltd, a spin-out company of University College London (UCL). It is designed to enhance the accuracy of prostate cancer diagnosis and treatment by guiding targeted biopsies and minimally-invasive therapies. The software fuses diagnostic information from magnetic resonance imaging (MRI) with real-time transrectal ultrasound (TRUS) images, creating a 3D model of the prostate and identifying malignancies. This allows clinicians to precisely target areas of concern during procedures. The system features a clinician-designed, intuitive user interface and is agnostic to specific MR and ultrasound equipment. Its core technology utilizes machine learning techniques to assure accurate deformation and compensate for changes in prostate shape and position between images. The technology and related assets of SmartTarget were acquired by Miami-based Intuitive Fusion LLC in January 2020 for inclusion in its Focalyx Fusion product.

Note: The provided prompt indicated this tool is for a ‘physician directory’. However, based on the K170250 FDA clearance and extensive search results, SmartTarget is a medical device for prostate image fusion and targeting, not a physician directory. This JSON reflects the actual product’s functionality.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • MRI-Ultrasound image fusion for prostate targeting
  • 3D reconstruction of transrectal ultrasound (TRUS) images
  • Real-time surgical guidance during biopsy and treatment
  • Precision targeting for prostate biopsy procedures
  • Supports minimally-invasive prostate cancer treatments (e.g., focal therapy)
  • Clinician-designed, intuitive user interface
  • Agnostic to specific MR and ultrasound equipment
  • Machine learning for accurate deformation of MR models
  • 2D and 3D image visualization features (review, multi-planar views, annotation)
  • Automated compensation for changes in prostate shape and position

Use Cases

  • Targeted prostate biopsy for cancer detection
  • Image-guided interventional procedures involving the prostate gland
  • Minimally-invasive prostate cancer treatments (focal therapy)
  • Enhanced visualization during prostate diagnostic and treatment procedures
  • Computer-assisted surgical planning for prostate cancer
  • Improving detection rates of clinically significant prostate cancer

What Physicians Need to Know

Key Capabilities
SmartTarget, integrated into Focalyx Fusion, offers advanced MRI-ultrasound image fusion for prostate cancer. It features bespoke algorithms for realistic deformation of MR models, mathematically best-fit image fusion, live needle guidance for precise positioning, and 3D visualization for maximum tumor core targeting. The system supports a transperineal approach and is energy-agnostic, compatible with various ablative modalities like cryoablation, HIFU, IRE, and laser ablation.
Clinical Utility
The tool provides precision targeting for prostate cancer biopsy and focal therapy, aiming to destroy cancerous lesions while preserving healthy tissue. This approach is associated with reduced infection risk due to the transperineal method and aims to improve patient outcomes by maintaining urinary and sexual function. Focalyx reports 86% of patients are cancer-free after 5 years, with 95% urinary improvement and 88% erectile retention.
Integration Options
Focalyx Fusion is designed to be agnostic to the clinic's existing MR and ultrasound equipment, allowing for seamless integration into current clinical workflows. It supports various treatment modalities, including cryoablation, HIFU, IRE, and laser ablation, making it adaptable to different therapeutic strategies.
Compliance Status
The original SmartTarget device was CE-marked. Focalyx Fusion has FDA 510(K) clearance (K170250). A Class 2 Device Recall was initiated in December 2025 due to potential functional issues with Windows 10, with a recommendation to stop use until verified/validated with Windows 11.
Pricing Model
While specific pricing details are not publicly disclosed, the original SmartTarget was described as 'affordable for both the public and private healthcare sectors.' Focalyx emphasizes its methodology as 'cost-effective' for treating prostate cancer.
User Experience
The system features a clinician-designed, intuitive user interface with a streamlined workflow, making it fast and easy for ultrasound and radiologist-friendly MR contouring. It is built around the urology workflow, aiming for quick team ramp-up and focus on the patient.
Support Quality
Focalyx offers comprehensive support including hands-on training, case observations, an easily accessible course, and 24/7 live remote support for planning and cases.
Implementation Complexity
The Focalyx system is designed for easy integration into any clinical setting, fitting seamlessly into existing urology practices with minimal disruption. Clinicians typically reach proficiency quickly through provided training.
Evidence Base
SmartTarget technology was developed by researchers at UCL's Centre for Medical Image Computing, with funding from the UK's Department of Health and the Wellcome Trust. The SmartTarget Biopsy Trial, a prospective, randomized, blinded trial, compared its accuracy. Focalyx also highlights a 5-year study demonstrating improved patient outcomes, including better urinary incontinence and sexual function, and high rates of being cancer-free.
Physician Tip

Consider Focalyx Fusion for patients with localized prostate cancer seeking a minimally invasive approach that prioritizes quality of life. The system's MRI-ultrasound fusion and precise targeting capabilities can enhance diagnostic accuracy and treatment delivery for focal therapy. Be aware of the recent Class 2 recall regarding Windows 10 compatibility and ensure your system is validated for Windows 11 or the recommended operating system. Leverage the 24/7 remote support and training to maximize proficiency and integrate the system smoothly into your practice.

Focalyx Fusion is designed to be highly adaptable, working with various manufacturers' ultrasound and MRI equipment. Its 'energy-agnostic' nature means it can guide a range of focal therapy modalities, including cryoablation, HIFU, IRE, and laser ablation, offering flexibility in treatment choice without requiring specific proprietary ablation devices. This broad compatibility facilitates integration into diverse clinical environments and existing treatment protocols.

Details

Category Oncology AI, Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — N/A
DeploymentOn-premise (PC-based software)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

K170250, cleared by the FDA on May 18, 2017, as a Class II medical device (Product Code LLZ - Picture archiving and communications system). It is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland, for enhanced visualization of two-dimensional (2D) transrectal ultrasound (TRUS) images of the prostate in clinic and hospital settings.
Integrations
EHR Not specified
Specialties Interventional Radiology, Radiology, Urology

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Press & Coverage

News-Medical.Net
Novel laser focal therapy device shows promising results for prostate cancer treatment
A clinical trial published in BJU International shows promising results for a novel cooled laser focal therapy device, ProFocalu00ae, for prostate cancer treatment, with 84% of patients cancer-free at 3 months post-treatment and an improved safety profile.
2026-01
PubMed (Journal of Endourology)
Transperineal MR Fusion Laser Ablation of Prostate Cancer in Office Setting: 1 Year Efficacy and Safety Outcomes in Intermediate-Risk Patients
This Phase I clinical trial evaluated Transperineal MRI fusion laser ablation (TPFLA) for intermediate-risk prostate cancer, showing it to be a safe and effective focal therapy with minimal periprocedural impact and 83% of patients free from clinically significant cancer at one year.
2025-01
AuntMinnie.com
CLS Americas inks partnership with Focalyx
Clinical Laserthermia Systems (CLS) Americas and Focalyx have partnered to co-market CLS's Tranberg thermal therapy system with Focalyx's Fusion image guidance system for image-guided focal laser ablation of prostate tumors.
2023-08
Focalyx Blog
In Just 90 minutes, everything can change
Focalyxu00ae TX, utilizing FDA-approved Focalized Cryoablation technology and Focalyxu00ae Fusion software, offers a non-invasive, quick-recovery, outpatient prostate cancer treatment that precisely targets cancerous lesions.
unknown
UCL Business Ltd (UCLB)
SmartTarget Ltd announces sale of technology to Miami-based Intuitive Fusion LLC
SmartTarget Ltd, a UCL spinout, sold its image fusion technology for prostate cancer targeting to Intuitive Fusion LLC, owner of the Focalyx Suite, which will integrate it into their Focalyx Fusion platform.
2020-01
PubMed (European Urology)
The SmartTarget Biopsy Trial: A Prospective, Within-person Randomised, Blinded Trial Comparing the Accuracy of Visual-registration and Magnetic Resonance Imaging/Ultrasound Image-fusion Targeted Biopsies for Prostate Cancer Risk Stratification
This trial compared visual-registration and computer-assisted MRI/ultrasound image-fusion (SmartTarget) targeted biopsies for prostate cancer, concluding that a combination of both strategies yielded the highest detection rate for clinically significant cancers.
2019-05
PubMed (Archivos Espau00f1oles de Urologu00eda)
Focalyx Dx, Bx, Tx et Apps: A novel contemporary fusion paradigm for the management of prostate cancer
This article introduces the Focalyx paradigm, a novel fusion approach for prostate cancer management aiming to improve quality of life by precisely targeting and destroying identifiable disease without adverse effects.
2016-07

Videos

Product demos, reviews, and walkthroughs for SmartTarget.

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Frequently Asked Questions

SmartTarget typically integrates with major EMR systems via APIs, aiming to seamlessly embed insights and minimize disruption to existing clinical workflows. While integration can be challenging with legacy systems, many EHR vendors are now building AI features directly into their platforms to enhance interoperability and streamline data flow at the point of care.
SmartTarget employs robust data privacy and security measures, including encryption, access controls, and de-identification techniques, to protect patient information. For HIPAA compliance, a Business Associate Agreement (BAA) is essential when handling Protected Health Information (PHI), and the system must adhere to privacy, security, and breach notification rules. Under GDPR and the EU AI Act, healthcare AI systems are often classified as high-risk, requiring explicit consent, data minimization, transparency, and human oversight to ensure compliance.
Like all AI, SmartTarget's algorithms may exhibit limitations or biases, often stemming from the training data, which could lead to misdiagnoses or suboptimal care for certain patient populations or rare conditions. It is crucial to remember that AI serves as a decision support tool, not a replacement for clinical judgment, and its outputs must always be critically evaluated. Transparency regarding the training data, model design, and potential limitations is typically provided to users.
Pricing models for healthcare AI solutions like SmartTarget commonly include subscription-based fees, per-user licenses, or usage-based models (e.g., per patient, per test, or per episode). While value-based or outcome-linked payment models are ethically appealing, they can be operationally complex to implement. Many vendors offer tiered pricing structures or special considerations for smaller practices, academic institutions, or research initiatives to facilitate adoption.
SmartTarget differentiates itself through its specific clinical focus, the breadth and quality of its integrated data sources, the explainability of its AI, and its user interface. While many AI-driven clinical decision support tools exist (e.g., UpToDate, Nuance DAX, Epic CDS tools), key comparisons often involve regulatory status, integration capabilities with existing EHRs, and the clinical evidence supporting its efficacy. Alternatives can range from other specialized AI platforms to traditional clinical guidelines and expert consultations.
Comprehensive training programs are typically offered, including online modules, webinars, and sometimes on-site sessions, to ensure physicians and staff can effectively utilize SmartTarget. Ongoing support usually includes dedicated technical assistance, regular software updates, and access to a knowledge base or community forum for best practices and troubleshooting. Training emphasizes understanding AI's capabilities and limitations, and how to critically review its outputs within clinical workflows.
Reputable AI solutions like SmartTarget should provide a strong evidence base, including peer-reviewed studies, clinical trials, and real-world data demonstrating its effectiveness in improving diagnostic accuracy, treatment efficacy, or patient outcomes. The evaluation of AI tools should encompass technical performance, usability within clinical workflows, and ultimately, their positive impact on healthcare delivery. It is important to note that AI is a decision support tool, and human expertise remains essential for high-quality care.

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