SmartTarget Ltd (now integrated into Focalyx Fusion by Intuitive Fusion LLC)

Miami, Florida, USA All United States companies → — Founded 2015

Imaging AI Specialist Medical Device / Hardware Specialty-Focused AI

Interventional Radiology Radiology Urology

Oncology AI Radiology & Imaging AI Surgical AI

Private (SmartTarget technology acquired)

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Products

SmartTarget

SmartTarget Ltd (now integrated into Focalyx Fusion by Intuitive Fusion LLC)

Oncology AI

SmartTarget is an AI-powered image fusion software for precision prostate cancer biopsy and focal therapy, originally developed by SmartTarget Ltd and now integrated into Focalyx Fusion. It combines MRI and ultrasound images for accurate targeting.

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About SmartTarget Ltd (now integrated into Focalyx Fusion by Intuitive Fusion LLC)

SmartTarget Ltd, originally a spin-out from University College London’s Centre for Medical Image Computing, developed CE-marked image fusion technology for precise transperineal targeting of prostate cancer. This technology was designed to be equipment-agnostic, user-friendly, and easily integrated into existing clinical workflows, aiming to improve patient outcomes through accurate biopsy guidance and enabling minimally invasive focal therapies.

In January 2020, SmartTarget Ltd’s technology and assets were acquired by Miami-based Intuitive Fusion LLC, becoming a core component of its Focalyx Fusion platform. Focalyx Fusion is an FDA-cleared Software as a Medical Device (SaMD) that leverages unique MRI/ultrasound image fusion for real-time surgical targeting of prostate cancer. It facilitates computer-assisted surgical planning and provides live guidance, allowing clinicians to precisely sample and ablate tumors while preserving healthy tissue.

The Focalyx paradigm, pioneered by Dr. Fernando Bianco, offers an all-inclusive approach to prostate cancer management, encompassing diagnosis (FocalyxDx), biopsy (FocalyxBx), and treatment (FocalyxTx) within an office setting. This system is compatible with various focal treatment modalities, including cryoablation, HIFU, IRE, brachytherapy, and laser ablation, with a primary focus on maintaining patients’ quality of life by preserving urinary and sexual functions.

Focus Areas

Prostate cancer diagnosis targeted prostate biopsy focal therapy MRI-ultrasound fusion minimally invasive treatments preserving quality of life real-time surgical guidance

Business Intelligence

Key Investors	Health Innovation Challenge Fund, Wellcome Trust, UK Department of Health, NIHR, UCL Business Ltd (UCLB)
Partnerships	SmartBlate LLC, CLS Americas
Acquisitions	SmartTarget Ltd (acquired by Intuitive Fusion LLC in January 2020); UK trademark 'SmartTarget' acquired by ViewRay Inc.
Technology	Deformable MRI-ultrasound fusion technology, AI-driven diagnostic & therapeutic targeted interventions, software-driven, real-time surgical guidance, compatible with various ultrasound machines, supports cryoablation, HIFU, IRE, laser ablation
FDA Clearances	1 cleared products (estimated)

What Physicians Need to Know

Prostate Cancer Diagnosis

Specializes in precise prostate cancer diagnosis using multiparametric MRI (mpMRI) and real-time ultrasound fusion to accurately locate suspicious lesions.

Targeted Prostate Biopsy

Offers highly accurate, targeted transperineal prostate biopsies guided by MRI-ultrasound fusion, significantly improving cancer detection rates and reducing the risk of infection compared to traditional methods.

Focal Therapy

Focuses on minimally invasive focal therapy, precisely targeting and destroying only cancerous lesions while preserving healthy prostate tissue and vital functions.

MRI-Ultrasound Fusion

Utilizes advanced, patented MRI-ultrasound image fusion technology with deformable fusion models that compensate for prostate and patient movement, providing a 'GPS-like' guidance system for diagnosis and treatment.

Minimally Invasive Treatments

Enables outpatient procedures, often completed within 60-90 minutes under local anesthesia, leading to faster recovery times, minimal discomfort, and reduced long-term side effects.

Preserving Quality of Life

A core mission is to maintain and improve patients' urinary and sexual functions by selectively treating cancer and sparing healthy tissue, a significant advantage over traditional aggressive treatments.

Real-time Surgical Guidance

Provides real-time surgical guidance by overlaying pre-operative MRI images with live ultrasound, offering clinicians confident targeting throughout planning and treatment.

Physician Tip

Focalyx Fusion by Intuitive Fusion LLC offers physicians a powerful, intuitive, and versatile platform for prostate cancer management. Its key differentiators include a patented deformable MRI-US fusion technology that ensures extreme accuracy by compensating for prostate and patient movement, providing 'GPS-like' precision for targeted biopsies and focal therapies. The system is designed with a simple, urologist-specific user interface and an intuitive workflow, allowing for quick setup and seamless integration into existing clinical practices, including in-office procedures under local anesthesia. This energy-agnostic platform supports various ablative modalities (cryoablation, HIFU, IRE, brachytherapy, laser ablation), giving physicians flexibility in treatment choices. The focus on preserving patient quality of life through minimally invasive, tissue-sparing focal therapy, coupled with an all-in-one solution for diagnosis, biopsy, and treatment planning (Focalyx Dx, Bx, Tx), makes it a compelling option for enhancing patient outcomes and practice efficiency. Furthermore, the system includes a proprietary app for patient-physician interaction and health monitoring, streamlining follow-up care. Comprehensive training and 24/7 remote support are also available to ensure successful adoption and utilization.

The Focalyx Fusion system is designed to be highly adaptable and compatible with various ultrasound machines and positioning systems, ensuring it can be easily integrated into diverse clinical settings without requiring significant changes to existing equipment or workflows. It is an FDA-cleared Software as a Medical Device (SaMD) and runs on a medical-grade PC with Windows 10. The platform's energy-agnostic nature allows for integration with different ablative technologies for focal therapy, such as cryoablation, HIFU, IRE, brachytherapy, and laser ablation. Data collection is managed through a proprietary encrypted storage app, which also facilitates patient-physician interaction within the Focalyx network.

At a glance

Founded 2015

HQ Miami, Florida, USA · United States

Team size 1-20

CEO Dr. Fernando Bianco

Funding Private (SmartTarget technology acquired)

FDA clearances 1 (estimated)

Products 1

Products by SmartTarget Ltd (now integrated into Focalyx Fusion by Intuitive Fusion LLC)

1 product in the directory

SmartTarget

SmartTarget Ltd (now integrated into Focalyx Fusion by Intuitive Fusion LLC)

Oncology AI

Contact for pricing

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Press & Coverage

SmartTarget

SmartTarget Ltd announces sale of technology to Miami-based Intuitive Fusion LLC

SmartTarget Ltd, a UCL spinout, sold its image fusion technology for accurate prostate cancer targeting to Intuitive Fusion LLC, owner of the Focalyx Suite, in a deal that includes a license agreement for underlying patents and software. The technology will be integrated into the Focalyx Fusion platform to support biopsy and focal therapy procedures.

2020-01

AuntMinnie

CLS Americas inks partnership with Focalyx

Clinical Laserthermia Systems (CLS) Americas partnered with Focalyx for image-guided focal laser ablation of prostate tumors, combining CLS's Tranberg thermal therapy system with Focalyx's Fusion image guidance system. This offering will be available through a mobile services provider agreement.

2023-08

PubMed

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 the safety and feasibility of Transperineal MRI fusion laser ablation of prostate cancer (TPFLA) as a focal therapy option for intermediate-risk patients, with results suggesting it is a safe and effective alternative to more radical treatments.

2025-01

accessdata.fda.gov

Class 2 Device Recall SmartTarget

The FDA issued a Class 2 recall for Focalyx Fusion software versions 1.3, 1.5, and 1.6 due to potential malfunction with Windows 10, which could cause patient harm or treatment delays during prostate biopsy or therapy. Focalyx Technologies, LLC, initiated correction notices to customers, recommending a stop-use until verification with Windows 11.

2026-02

PubMed

Focalyx Dx, Bx, Tx et Apps: A novel contemporary fusion paradigm for the management of prostate cancer

This article details the Focalyx paradigm, a novel approach to prostate cancer management that utilizes optimized MRI imaging and fusion platform software to precisely locate, diagnose, and treat cancer while aiming to improve patients' quality of life.

2016-07

PubMed

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 clinical trial compared visual-registration and computer-assisted MRI/ultrasound image-fusion (SmartTarget) for targeted prostate biopsies, concluding that a combination of both strategies yielded the highest detection rate for clinically significant cancers.

2019-05

PRWeb

New Imaging Fusion Target Breakthrough in the Diagnosis and Management of Prostate at Urology Specialist Group

Dr. Fernando Bianco and his team developed Focalyx Dx, Bx, Tx, an office-based approach for prostate cancer management that uses specialized MRI and GPS-like precision to target and destroy cancer while sparing healthy tissue, significantly improving patient quality of life.

2017-11

Focalyx

Focalyx - Minimally Invasive Cancer Eradication

Focalyx offers a cutting-edge, minimally invasive treatment methodology for prostate cancer, designed to precisely locate, diagnose, and treat cancerous cells while preserving the prostate and improving the patient's quality of life. The company highlights clinically proven outcomes, including high rates of cancer elimination and improved urinary and sexual function.

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Frequently Asked Questions

How does Focalyx Fusion, incorporating SmartTarget technology, enhance the accuracy of targeted prostate biopsies for prostate cancer diagnosis?

Focalyx Fusion integrates pre-operative multiparametric MRI with real-time ultrasound, enabling precise targeting of suspicious lesions within the prostate. This fusion model, which accounts for prostate deformation, significantly improves the accuracy of targeted biopsies compared to traditional methods, leading to better detection of aggressive prostate cancer and reducing the need for repeat procedures.

What role does Focalyx Fusion play in facilitating minimally invasive treatments and focal therapy for prostate cancer, particularly concerning the preservation of patient quality of life?

Focalyx Fusion provides precise, real-time guidance for focal therapy, allowing urologists to target and ablate only cancerous lesions while sparing healthy prostate tissue. This minimally invasive approach aims to reduce side effects commonly associated with whole-gland treatments, such as urinary incontinence and erectile dysfunction, thereby preserving the patient's quality of life.

Can you elaborate on the real-time surgical guidance capabilities of Focalyx Fusion and how they benefit urologists during prostate interventions?

Focalyx Fusion offers a 'GPS-like' system that overlays pre-operative MRI data onto real-time ultrasound images, providing urologists with confident targeting throughout planning and treatment. This real-time visualization and guidance facilitate precise navigation during procedures, improving efficiency and enhancing the accuracy of interventions like biopsies and focal ablations.

What regulatory clearances and compliance standards does Focalyx Fusion (with SmartTarget technology) meet for clinical use in prostate cancer diagnosis and treatment?

The SmartTarget technology, now integrated into Focalyx Fusion, was CE-marked, indicating compliance with European health, safety, and environmental protection standards. While specific FDA clearances for Focalyx Fusion were not detailed in the provided search results, medical devices used in the US market are subject to FDA regulations to ensure safety and efficacy.

Given the integration of SmartTarget Ltd into Focalyx Fusion by Intuitive Fusion LLC, what assurances can be provided regarding ongoing product support, future innovations, and the overall stability of the company?

The acquisition of SmartTarget's technology by Intuitive Fusion LLC was intended to provide added investment and support, incorporating the leading fusion technology into the Focalyx Suite. This integration leverages Intuitive Fusion's resources for continued product development, support, and a stable platform for users, with a focus on ongoing innovation in prostate cancer care.

From a healthcare administrator's perspective, what is the economic value proposition of implementing Focalyx Fusion for prostate cancer care, considering initial costs and long-term benefits?

Implementing Focalyx Fusion offers an economic value proposition through improved diagnostic accuracy, potentially reducing the need for repeat biopsies and associated costs. Its ability to facilitate minimally invasive, in-office procedures can also lead to reduced hospital stays and quicker patient recovery, contributing to overall cost efficiencies and better resource utilization.

What kind of training and implementation support does Intuitive Fusion LLC provide for healthcare facilities adopting the Focalyx Fusion system?

Intuitive Fusion LLC offers comprehensive training and support for Focalyx Fusion, including hands-on training experiences, case observations, and easily accessible courses. The system is designed with a simple user interface and intuitive workflow to ensure quick team ramp-up and seamless integration into existing clinical settings.

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