CE Mark

Exact Imaging wins CE Mark for transperineal needle

Exact Imaging today said it received CE Mark approval for its Sterile Transperineal Needle Guide for use with its EV29L transducer.

The Sterile Transperineal Needle Guide, when used with the ExactVu micro-ultrasound system, allows urologists to perform targeted prostate biopsies using the near-microscopic resolution of the micro-ultrasound.

“In some markets, there is increasing movement toward transperineal-based biopsies, with the aim of reducing rates of infections,” president and CEO Randy Aucoin said in a press release. “With the CE Mark for our new Sterile Transperineal Needle Guide, the ExactVu micro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu and cognitive fusion biopsies.”

“The ability to perform targeted transperineal biopsies guided by ExactVu 29 MHz micro-ultrasound represents a real breakthrough by virtue of being able to image the target volume in real-time in the office,” Mark Emberton, professor of interventional oncology, division of surgery and interventional science at University College London, said.

Original Article: (https://www.massdevice.com/exact-imaging-wins-ce-mark-for-transperineal-needle/)

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