Technology | Ultrasound Imaging | October 24, 2019

New Sterile Transperineal Needle Guide enables the ExactVu micro-ultrasound system to be used for real-time targeted biopsies in clinical settings requiring transperineal access

Exact Imaging Receives FDA 510(k) Clearance for Sterile Transperineal Needle Guide

October 24, 2019 — Exact Imaging received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sterile Transperineal Needle Guide for use with the Exact Imaging EV29L transducer. Operating on the ExactVu micro-ultrasound system, the Sterile Transperineal Needle Guide now allows urologists to perform targeted prostate biopsies, leveraging the near microscopic resolution of the micro-ultrasound for transperineal-based biopsies. The ExactVu system provides the highest real-time resolution for guidance of prostate biopsies and may now be used in procedures that use transperineal approaches for prostate biopsies.

Exact Imaging President and CEO Randy AuCoin said the new needle guide reflects a trend in the industry toward transperineal-based prostate biopsies as an option to reduce the risk of infection. The ExactVu miro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu and cognitive fusion biopsies. 

“The ExactVu technology broadens my prostate biopsy options and can be performed in the clinic or in an outpatient surgery center,” said Neal D. Shore, M.D., FACS, medical director for the Carolina Urologic Research Center and the national urology research director for 21st Century Oncology. “As transperineal biopsy strategies evolve, potentially for enhanced tissue procurement, and therefore, enhanced histopathologic evaluation as well as the likelihood for decreased infectious complication risk, performing targeted transperineal biopsies using the ExactVu 29 MHz micro-ultrasound system optimizes the performance of prostate biopsy.”

ExactVu micro-ultrasound system, its FusionVu application along with the newly released Sterile Transperineal Needle Guide, will be showcased live at the Large Urology Group Practice Association (LUGPA) 2019 annual meeting, Nov. 7-9 in Chicago, 2019 and the 28th Annual Perspectives in Urology: Point Counterpoint, Nov. 14-16 in Scottsdale, Ariz.

For more information: www.exactimaging.com


Related Content

News | RSNA

November 23, 2022 — The Radiological Society of North America (RSNA) has announced the official results of the RSNA ...

Time November 23, 2022
arrow
News | Radiology Business

November 16, 2022 — It is with great sadness that Exo, a medical imaging software and device company, today announces ...

Time November 16, 2022
arrow
Feature | Ultrasound Imaging | By Adil Khan

Ultrasound has the potential to interact mechanically and thermally with human tissue, and can even penetrate deep into ...

Time November 01, 2022
arrow
News | ASTRO

October 26, 2022 — CIVCO Radiotherapy, a global provider of radiotherapy solutions, has announced it is joining forces ...

Time October 26, 2022
arrow
News | Artificial Intelligence

October 7, 2022 — Exo (pronounced “echo”), a pioneering health information and medical devices company, announced that ...

Time October 07, 2022
arrow
News | Enterprise Imaging

October 3, 2022 — Butterfly Network, Inc., a digital health company transforming care through the power of handheld ...

Time October 03, 2022
arrow
News | ASTRO

The 64th Annual Meeting of the American Society for Radiation Oncology (ASTRO) will take place October 23-26, at the ...

Time September 29, 2022
arrow
News | Point-of-Care Ultrasound (POCUS)

September 27, 2022 — Fujifilm Sonosite, Inc. – the world leader in point-of-care ultrasound (POCUS) solutions – has ...

Time September 27, 2022
arrow
News | Ultrasound Women's Health

September 21, 2022 — Butterfly Network, Inc. (NYSE: BFLY), a digital health company transforming care through the power ...

Time September 21, 2022
arrow
Feature | Ultrasound Women's Health | By Roberta Kline, MD and Robert L. Bard, MD, DABR, FASL

An estimated 24% of women in the United States will suffer from a pelvic floor disorder in her lifetime, with that ...

Time September 15, 2022
arrow
Subscribe Now