News | Prostate Cancer | December 09, 2016

New Disruptive Prostate Micro-Imaging and Biopsy System Approved for Commercial Release in the United States

Exact Imaging Receives FDA 510(k) Clearance for Its ExactVu Micro-Ultrasound System

Exact Imaging, a leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced it has received FDA 510(k) Clearance for its ExactVu micro-ultrasound system.

"This has been a great few weeks with the receipt of our 510(k) clearance and the announcement of our CE approval just two weeks ago," said Randy AuCoin, Exact Imaging's president and CEO. "These important regulatory approvals will allow our commercial team to start fulfilling the pent-up demand for the ExactVu micro-ultrasound system. The era of blind, unguided biopsies is coming to an end and urologists are searching for new tools that leverage break-through technologies, familiar workflows and allow them to benefit from improved imaging resolution to target their prostate biopsies. Our platform is such a solution — it images in real-time, it is located in the urologist's office, and it is ultrasound-based. Most important, it allows for the guidance of both systematic and targeted biopsies due to its exquisite resolution."

With resolution down to 70 microns — or 0.07 of a millimeter, the ExactVu high resolution system provides a 300 percent improvement in imaging resolution compared to the traditional standard-of-care urological ultrasound systems. Urologists now have a tool, designed around their workflow, to facilitate the detailed interrogation and visualization of suspicious regions and perform targeted prostate biopsies.

The ExactVu micro-ultrasound recently received CE marking enabling sales of the system in Europe.  Exact Imaging's European commercial operations are being set-up in its new European headquarters in Belgium.  With this 510(k) clearance, North American sales, clinical applications and technical support teams are being expanded to support the anticipated growth in US customers.

For more information: www.exactimaging.com

Related Content

News | Ultrasound Imaging

October 15, 2021 — NeuroLogica Corp., the U.S. healthcare subsidiary of Samsung, introduces the V8; a high-end ...

Time October 15, 2021
arrow
News | Radiology Imaging

October 6, 2021 — According to ARRS’ American Journal of Roentgenology (AJR), liver stiffness measurements (LSM) ...

Time October 06, 2021
arrow
Feature | Cardiac Imaging

October 6, 2021 – A new study published in Radiology: Cardiothoracic Imaging on cardiac imaging trends over a decade ...

Time October 06, 2021
arrow
News | Cardiovascular Ultrasound

October 5, 2021 – UltraSight, a digital health company developing artificial intelligence (AI) enabled cardiac imaging ...

Time October 05, 2021
arrow
News | Ultrasound Imaging

October 5, 2021 — Ultrasound experts urged the health care community to work to expand utilization of ultrasound ...

Time October 05, 2021
arrow
News | Radiology Business

September 27, 2021 — Esaote, an Italian company leader in the biomedical equipment sector – ultrasound, MRI and software ...

Time September 27, 2021
arrow
News | Prostate Cancer

September 24, 2021 — Scientists have identified two subtypes of metastatic prostate cancer that respond differently to ...

Time September 24, 2021
arrow
News | Ultrasound Imaging

September 24, 2021 — According to ARRS’ American Journal of Roentgenology (AJR), recent European multisociety guidelines ...

Time September 24, 2021
arrow
News | Radiology Business

September 23, 2021 — GE has entered into an agreement to acquire BK Medical, a leader in advanced surgical visualization ...

Time September 23, 2021
arrow
News | Digital Pathology

September 22, 2021 — The U.S. Food and Drug Administration authorized marketing of software to assist medical ...

Time September 22, 2021
arrow
Subscribe Now