[fusion_builder_container hundred_percent="no" hundred_percent_height="no" hundred_percent_height_scroll="no" hundred_percent_height_center_content="yes" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" status="published" publish_date="" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" enable_mobile="no" parallax_speed="0.3" video_mp4="" video_webm="" video_ogv="" video_url="" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" video_preview_image="" border_size="" border_color="" border_style="solid" margin_top="" margin_bottom="" padding_top="" padding_right="" padding_bottom="" padding_left=""][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" spacing="" center_content="no" link="" target="_self" min_height="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="left top" background_repeat="no-repeat" hover_type="none" border_size="0" border_color="" border_style="solid" border_position="all" padding_top="" padding_right="" padding_bottom="" padding_left="" margin_top="" margin_bottom="" animation_type="" animation_direction="left" animation_speed="0.3" animation_offset="" last="no"][fusion_text columns="" column_min_width="" column_spacing="" rule_style="default" rule_size="" rule_color="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id=""] ♦ CEO Janet Campbell wins a Gold Stevie® Award for Female Entrepreneur of the Year in the 10th annual Stevie Awards for Women in Business 2013. Ms. Campbell received the honor in the consumer products category representing companies with 11 to 2,500 employees. ♦ Enrolls first 100 patients in its Pivotal Study of Imagio®. ♦ Announces preliminary information from a feasibility study of its Imagio® breast imaging device. Data presented at the annual meeting of the Radiological Society of America (RSNA) and at the San Antonio Breast Cancer Symposium (SABCS). [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

FAQs Archive – Seno Medical

Q: 8. Are there on-going clinical studies with this technology?

Seno has recently completed a pivotal study in the US and a post-market surveillance and clinical follow-up study in Europe to evaluate if this non-invasive imaging system (non-ionizing radiation, no injected contrast agents) has the potential to help doctors more effectively determine which patients need biopsies. Please watch this Website for information about future clinical trials and results.

Q: 6. Is this technology patented?

Patents have been filed for the various aspects of Seno’s opto-acoustic imaging system and its technology. Additionally, because of the nature of the science and engineering on which the technology is based, significant expertise resides within the Seno team.

Q: 4. What is the pathway for regulatory approval?

The pathway of approval for sale and use of Seno’s opto-acoustic imaging system is governed by the Food and Drug Administration (FDA) Center for Devices and Radiological Health. The FDA’s Office of Device Evaluation is responsible for ensuring the safety and effectiveness of the medical devices available to U.S. consumers and does so based on documentation collected by the device manufacturer. Although optical and ultrasound devices are both already used clinically, the unique combination of technologies present in Seno’s opto-acoustic tomography system will require a regulatory approval process reserved for new technologies, which is known as a Pre-Market Approval .

Q: 3. When will a device usable for humans be ready?

[fusion_builder_container hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4="" video_webm="" video_ogv="" video_url="" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" overlay_color="" video_preview_image="" border_size="" border_color="" border_style="solid" padding_top="" padding_bottom="" padding_left="" padding_right=""][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" border_position="all" spacing="yes" background_image="" background_repeat="no-repeat" padding_top="" padding_right="" padding_bottom="" padding_left="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" min_height="" hover_type="none" link=""][fusion_text columns="" column_min_width="" column_spacing="" rule_style="default" rule_size="" rule_color="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id=""] 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. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Q: 2. How is opto-acoustic imaging different from conventional ultrasound?

[fusion_builder_container hundred_percent="no" equal_height_columns="no" menu_anchor="" hide_on_mobile="small-visibility,medium-visibility,large-visibility" class="" id="" background_color="" background_image="" background_position="center center" background_repeat="no-repeat" fade="no" background_parallax="none" parallax_speed="0.3" video_mp4="" video_webm="" video_ogv="" video_url="" video_aspect_ratio="16:9" video_loop="yes" video_mute="yes" overlay_color="" video_preview_image="" border_size="" border_color="" border_style="solid" padding_top="" padding_bottom="" padding_left="" padding_right=""][fusion_builder_row][fusion_builder_column type="1_1" layout="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" border_position="all" spacing="yes" background_image="" background_repeat="no-repeat" padding_top="" padding_right="" padding_bottom="" padding_left="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="small-visibility,medium-visibility,large-visibility" center_content="no" last="no" min_height="" hover_type="none" link=""][fusion_text] The existing optical and ultrasonic imaging techniques create images by transmitting energy in one form and detecting that energy in the same form, which greatly limits the information that can be captured and reported. Opto-acoustics transmits light energy, but detects sound energy by using multiple colors of laser light, a much broader range of data can be captured which makes the functional images possible. [/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

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