FDA Clears Exact Imaging's FusionVu Application for Its Biopsy Platform

The US Food and Drug Administration (FDA) has cleared the use of FusionVu, an application on the ExactVu micro-ultrasound system that allows for urologists to perform cognitive fusion through its Cognitive Assist function or micro-ultrasound/MR fusion on the platform.

Exact Imaging’s product allows for the fastest and simplest real-time targeting of prostate biopsies while also providing the highest resolution in real-time guidance for them, according to the company.

"Our goal is to provide urologists with the best information in real time so that they can visualize suspicious regions and optimally target their prostate biopsies. We are excited to have received FDA 510(k) clearance, as well as our CE mark approval for our FusionVu application," Randy AuCoin, Exact Imaging's president and CEO, said in a statement. "Our growing global customer base will now have an even more comprehensive suite of applications by which to leverage the 70-micron resolution of the ExactVu platform to visualize the prostate, differentiate suspicious tissue and to guide targeted prostate biopsies in the fastest, simplest and most cost-effective manner."

The Cognitive Assist function of the application allows for the urologist to quickly and easily import radiological reports from magnetic resonance imaging (MRI) scans or to import annotated MR images on their own. The images are then co-aligned with the live micro-ultrasound imagery, allowing the urologist to identify and target lesions using PRI-MUS and ExactVu systems.

Urologists can also control MRI-identified lesions to confirm none were missed during the total biopsy procedure. The FusionVu application does not require any new hardware or radiological software and is focused on the standard workflow of urologists.

“It is easy to implement, easy to learn—because it's ultrasound-based—and cost-effective to implement,” according to Exact Imaging.

The FusionVu application was approved for use in the European Union in March. It was presented for the first time at the European Association of Urology 2017 Annual Congress in London, UK.

The ExactVu system and its newly approved application—including the company’s Cognitive Assist—will be demonstrated in a live event at the American Urological Association’s Annual Meeting in San Francisco, California, held May 18 to 21, 2018.