Focal Healthcare Receives FDA 510(k) Clearance and Health Canada Approval for Fusion Bx™ 2.0

Fusion Bx™ 2.0 leverages MRI/Ultrasound fusion technology to provide targeted prostate biopsies

TORONTO, CANADA – Focal Healthcare, an innovator of image-guided prostate cancer technology, announced it has received both FDA 510(k) clearance and Health Canada approval for its Fusion Bx™ 2.0 prostate biopsy solution. The Fusion Bx 2.0 is now available for sale in the United States and Canada. This is the second generation of Focal Healthcare’s prostate fusion biopsy device.

Fusion biopsies are quickly becoming the new standard of care in urological practices around the world. Using MRI to identify potential lesions and fusing this information to live ultrasound images creates a 3D model of the prostate that enables urologists to easily target specific regions for biopsy. As a result urologists can provide more accurate and meaningful prostate cancer diagnoses to their patients.

“We are committed to improving the state of prostate cancer care and with the Fusion Bx 2.0 we believe we have the most accurate and easy-to-use fusion biopsy system,” said Chicuong La, CEO of Focal Healthcare. “The Fusion Bx 2.0 has been designed with the goal of eliminating many of the sources of inaccuracies that plague systems today. Additionally, we recognized early on that the urologist’s time is incredibly valuable, so we made the interface easy to learn and operate. We are excited for the approvals and look forward to making our device accessible to urologists and their patients everywhere.”

Focal Healthcare’s new Fusion Bx 2.0 is equipped to help urologists perform fusion biopsy procedures even more efficiently and accurately than before. The new device features:

  • A semi-robotic arm with unrestricted range of motion that allows freehand-like access to the entire gland while providing consistent probe pressure and minimizing deformation.
  • Automatic motion compensation which adjusts for patient movement to maintain image registration, allowing procedures to continue uninterrupted.
  • Patented hands-free counterbalance technology that simplifies procedures by supporting the probe in any position and reduces the need for additional assistance.
  • A step-by-step guided workflow combined with semi-automatic segmentation that enables urologists to perform procedures in less time and with minimal training.
  • Compatibility with many leading ultrasound machines and probes and support for both end-fire and side-fire workflows.

To schedule a trial of the Fusion Bx 2.0, contact Focal Healthcare by phone at +1 647-479-9603 or by email at [email protected].

 About Focal Healthcare Inc.

Focal Healthcare is a Canadian-based medical device company committed to improving the lives of prostate cancer patients and their families through technical innovation. By developing imaging tools that emphasize accuracy, efficiency and accessibility, Focal Healthcare strives to advance prostate cancer diagnosis and management in clinics and hospitals of all sizes. Focal Healthcare designs and manufactures all its products at its headquarters in Toronto, Canada.