The next application that the UltraVision is being prepared for is the Breast Cancer Market. Components for this market are in the following status:
- B-Mode for solid vs cyst determinations is FDA approved and may be sold today.
- Fine needle Biopsy Guidance is just a software algorithm and is available today.
- Color Flow Doppler for evaluation of vascularity is FDA approved and may be sold today.
- Compression Elastography for evaluation of relative tissue hardness is approved and may be sold today.
- Shear Elastography for the quantitative estimation of tissue hardness is in the final development stage and requires FDA approval so is estimated to be available for sale in mid 2020.
- Visualization of microcalcifications is an algorithm which does not effect the power output so will be available in the first half of 2020 and is yet to be determined if it requires FDA approvals but any claims of efficacy will require FDA approval and such claims cannot be made until the completion of a proposed NIH grant which will require approximately 3 years to be sufficiently complete.
- An Automatic Breast Screening System attachment to the UltraVision is in concept phase and is expected to be available to the market within 2 years.
We are seeking partners to assist in these developments.