The Focalyx Fusion is an FDA cleared Software as a Medical Device (SaMD) designed for the real-time surgical targeting of prostate cancer. Developed using unique MRI/US image fusion technology, the Focalyx Fusion allows clinicians to accurately sample and destroy tumors while sparing healthy tissue.

The software supports computer-assisted surgical planning and provides a tool for real-time surgical guidance by reproducing and supplementing the visual information provided by real-time ultrasound imaging. The device is compatible with various ultrasound machines and quickly set up to be used with ease into existing clinical workflows.

The intended use of the system is to superimpose a graphical representation of one or more surgical targets on to real-time US images of the prostate to support targeted needle guidance in the diagnosis or treatment of prostate cancer.

Key Device Features

  • Ease of Use

    Quick and easy user interface specific to urologists

  • Precision

    Extreme accuracy for optimized targeting

  • Portability

    Smallest footprint in the market

  • Adaptability

    Compatible with all biplane ultrasounds and positioning systems

  • Real-Time

    Live Guidance

Technical Specifications

A medical grade PC is recommended to host the software. Medical grade host PC with these minimum requirements for the host PC are as follows:

  • Processor: Intel® Core™ i5 or i7 2655LE 2.2GHz Processor

  • Memory: 16GB RAM

  • Hard Drive: 100GB

  • Peripheral Ports: 4 x USB 2 (for keyboard, mouse, flash drive and USB stepper device)

  • Peripheral Ports and Interfaces: 1 x USB 3 (For external capture card) or 1 x PCIe x1 Gen 2-X (For internal capture card)

  • I/O Ports: 1-chanell DVI-I/S-Video/HDMI video input

  • Display Resolution: 1920 x 1200

  • Display Size: 21.5” LCD (max resolution 1920 x 1080)

  • Operating System: Windows 10

  • Standards: IPX1 Water Resistant Enclosure, IP65 Dust-tight Front Panel, UL60601-1/EN60601-1

  • Compatible capture cards: Advantech DVP-7012HE/DVP-7013HE, Yuan SC542N1, Epiphan Video DVI2USB3.0

The computer shall comply with IEC/EN 60601-1-2 electrical safety regulations.

Accessories

  • Keyboard & Mouse : A medical grade keyboard and mouse is required to interface with the host PC.

    • The keyboard and mouse should be IEC 60601-1-2 and IEC 60529 (IP65), enabling the devices to be wiped clean

  • USB drive: To protect confidential data and prevent tampering the recommend USB drive used has 256-bit AES hardware-based encryption and FIPS 140-2 Level 3 validation with on-device Cryptochip Encryption Key management (XTS-AES 256-bit, FIPS 140-2 level 3)

  • Ultrasound machine with these minimum requirements:

    • Digital or analog ultrasound machines: minimum requirements for the US machine are a video output port (S-video, HDMI, DVI, VGA)

    • A biplane (convex/linear) transrectal transrectal probe for transperineal applications.  Note: End-fire probes are not supported

    • Probe steppers: minimum requirements for the stepper are position encoders

  • Stepper : A stepper with electronic position encoders tracking angular and linear position