High Resolution Micro-Ultrasound System and Transducers

Waiver Rationale Summary

The ExactVu | Focal One Micro-Ultrasound Imaging System and Transducers is the only ultrasound platform in the world that has the architecture to support both a high frequency (29 MHz) and a conventional (3-12 MHz) transducer, which provides a total urological imaging solution in one platform. In addition, it is the only commercial ultra-sound system for clinical urological applications that operates at 29 MHz and enables resolution down to 70 μ, allowing Urologists to target areas without the need for a secondary modality like magnetic resonance imaging (MRI). ExactVu | Focal One Micro-Ultrasound Imaging System and Transducers can help Urologists identify and stratify the possible severity of micro-ultrasound-based characteristics of the prostate through prostate risk identification using micro-sound capabilities. This tool can help identify the characteristics of potentially significant lesions and other suspicious regions. The ultrasound system can be used in place of an MRI and has proven to render quality images 300% better than conventional ultrasounds. Additional EV29L transducers are necessary to expand and facilitate clinical research in prostate cancer diagnoses. The EV29L transducers are also proprietary and specific to the ExactVu | Focal One Micro-Ultrasound Imaging System and Transducers ultrasound system and are also only available from the Original Equipment Manufacturer (OEM) authorized distributor, Fidelis Sustainability Distribution, LLC. Fidelis Sustainability Distribution, LLC. is currently the only firm capable of providing the ExactVu | Focal One Micro-Ultrasound Imaging System and Transducers micro-ultrasound system and required transducer accessories.