The Imagio® breast imaging system – opto-acoustic fused with ultrasound (OA/US) – is currently CE marked in Europe with commercial delivery of the product expected mid-2017. The Imagio® OA/US breast imaging system is currently being processed through the U.S. FDA system of approval. That approval is expected early 2018 with sales in the U.S. immediately after approval.
3. When will a device usable for humans be ready?