Navigation Links
Focal Healthcare’s Fusion Bx 2.0 Targeted Prostate Biopsy Solution Receives CE Mark
Date:11/5/2019

Focal Healthcare, an innovator of image-guided prostate cancer technology, announced it has received CE Mark for its Fusion Bx 2.0 prostate fusion biopsy solution. By combining information from multiparametric MRI (mpMRI) with a semi-robotic arm and user-friendly interface, the Fusion Bx 2.0 will give urologists across Europe the ability to perform targeted transrectal and transperineal prostate biopsies.

Earlier this year, both the European Association of Urology (EAU) and the National Institute for Health and Care Excellence (NICE) released updated guidelines that recommend the use of mpMRI prior to biopsy, followed by a targeted biopsy when the MRI is positive. This diagnostic pathway reduces the number of biopsies while increasing the likelihood of finding significant cancers. These recommendations highlight the important role played by MRI/Ultrasound fusion technology and the need for an accurate and accessible device such as the Fusion Bx 2.0.

“We are excited to receive the CE Mark as it greatly expands the market for our Fusion Bx,” said Chicuong La, CEO of Focal Healthcare. “The results from last year’s PRECISION trial has changed the way in which prostate cancer is being diagnosed in Europe. Now urologists throughout the EU will have access to our Fusion Bx – providing them with a targeted biopsy system that is accurate, and simple to learn and use. This will make it easier for clinics and hospitals of all sizes to adopt the new guidelines.”

Focal Healthcare’s Fusion Bx 2.0 provides urologists with the ability to perform both transrectal and transperineal biopsies using a simple and intuitive interface. Fusion Bx 2.0 features:

  • A semi-robotic arm that keeps the probe steady to ensure consistent pressure on the prostate, limiting movement and deformation, thereby leading to increased accuracy
  • A 3D model that allows the urologist to visualize the prostate and MRI targets in real-time to guide the biopsy needle to the regions of interest
  • Automatic motion compensation which adjusts for patient movement to maintain image registration, allowing procedures to continue uninterrupted
  • A step-by-step guided workflow combined with semi-automatic segmentation that enables urologists to perform procedures in less time and with minimal training

Fusion Bx 2.0 will be available to European physicians through distribution. Fusion Bx 2.0 is also cleared for sale in Canada, USA and Taiwan. For more information, contact Focal Healthcare at sales@focalhealthcare.com.

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.

Read the full story at https://www.prweb.com/releases/focal_healthcares_fusion_bx_2_0_targeted_prostate_biopsy_solution_receives_ce_mark/prweb16657872.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related biology technology :

1. Mann Eye Institute Offers Whats Been Called the "Biggest Advancement in Reading Vision Since the Bifocal"
2. ImageXpress Micro Confocal High-Content Imaging System Expands the Boundaries of Research
3. AMA Recognized as the Focal Point for Aero-modeling
4. L3 Healthcare’s Clinical Trials Division Becomes Certified Designer for iMedNet eClinical and Electronic Data Management Software
5. Dr. Alexios Apazidis Completes Successful Discectomy & Fusion Surgery Using SpineFrontier's A-CIFT SoloFuse™ Less Exposure Surgery Technology
6. Alevio® completes the 500th case with SiCure™ Sacroiliac Fusion System
7. FACIT-Seeded Fusion Pharmaceuticals Closes US$25M Series A Led by Johnson & Johnson Innovation
8. Interbody-Fusion Outcomes May Be Improved by Use of Invibio's PEEK-OPTIMA™ HA Enhanced Polymer
9. Vertera Spines COHERE Fusion Device Wins Award For Best Spine Technologies for 2016
10. Newly Published Spine Surgery Study Shows Cervical Total Disc Replacement To Provide Better Results Than Fusion in Outpatient Setting
11. Amarantus Announces Capital Infusion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/7/2020)... (PRWEB) , ... August 06, 2020 , ... ... DNA vaccine industries, announces it has closed on the purchase of greenfield for ... in Conroe, TX and includes over 21 acres in the initial acquisition, with ...
(Date:7/31/2020)... ... 29, 2020 , ... G-CON Manufacturing, the leader in off-site ... FOR LIFE.” The adoption of this taglines comes at a time of tremendous ... to provide patients with urgently needed vaccines and other lifesaving pharmaceutical treatments. G-CON’s ...
(Date:7/31/2020)... ... , ... eSource has long been touted as the solution to high data ... the reasons it did not take off as quickly as people initially expected, and ... moving towards capturing data electronically for clinical trials and then repurposing it for downstream ...
(Date:7/18/2020)... ... July 16, 2020 , ... After research model surgery and ... a great surgery is only the beginning of a successful study, while protecting and ... Join Brad Gien, Global Head of Surgery from Envigo in a ...
Breaking Biology Technology:
(Date:7/10/2020)... ... July 08, 2020 , ... Overcoming Comparability ... Regulation, An FDAnews Webinar, Wednesday, July 22, 2020 • 1:30 p.m.-3:00 p.m. EDT, ... is the most effective way to complete one? Will the study comply with ...
(Date:7/2/2020)... ... July 02, 2020 , ... Dutch ... the use of its revolutionary NEXTGENPCR endpoint thermocycler to test for SARS-CoV-2 ... The article, titled "Ultra-fast one-step RT-PCR protocol for the detection of SARS-CoV-2," ...
(Date:6/28/2020)... ... June 25, 2020 , ... In an upcoming episode scheduled for the ... of Care Testing solutions (POCT). Check local listings for more info. , Today, the ... and are shipped to labs throughout the country. Results are then available several days ...
Breaking Biology News(10 mins):