Medical Use Case
Key Terms
Ultrasound
At-home
Direct to Consumer
High Risk
Wearable Scanner
3D Printing
On-Demand Production
Monitoring
Low Cost, Distributed Sensors
Non-motorized
Ultrasound Computed Tomography
This medical device company has developed technology for the detection of breast tumors that occur between regularly scheduled mammograms. These cancers tend to be more aggressive than those found in routine scans.
To use, the patient occasionally wears a bra that has cups to hold an array of low-cost ultrasound sensors that surround the breast. These sensors scan the breast to create a series of 2D image slices. These slices are then combined into a 3D model using a variation of Computed Tomography. Because the low-cost, distributed sensors collect enough 2D data to create a 3D model, there is no need for a motorized or stationary scanner. Therefore, the patient can have a breast ultrasound on-demand just by wearing the scan bra.
The cup or frame holding the ultrasound sensors is 3D printed in various standard bra sizes. Custom sizes can be created when the patient submits size, shape, and volume dimensions which can be done using a smartphone.
This ease of use allows a patient to have the option of direct-to-consumer delivery of the scanner and limits the need for office or clinic visits.
Attached to the scan bra is a battery-powered control and data collection box. This box controls the ultrasound scan and collects the data on a solid-state hard drive. After the scan session, the bra is removed and the control box is connected to a smartphone or computer for transmission to the cloud-based AI system for processing.
The first step of the processing is to confirm the identity, time, date, and location of the scan. This data is matched to the Certified patient file and each of the 2D scans has an identifier code attached to it. This code does not include the patient information, it is a pointer to that information so it is separated for patient confidentiality.
The AI system applies the Computed Tomography algorithm to create a 3D model that includes all instances of divergent acoustic properties which can actually be a tumor or lesion.
The AI would then highlight any divergent areas which would trigger a review by a qualified clinician. The review would become part of the patient record in the Certified AI database
The following scans would then be compared using AI with an emphasis on changes in divergent areas and prior reviews.
Summary
The result of the initial and following scans is a uniform and documented study of each patient with the opportunity to detect interval cancer with each scan. Because ultrasound does not have any known health risks and the scan can be done at an extremely low cost, the frequency of scans can be determined by the relative risk profile of the patient.
Because the data collected following the Certified AI Database©protocol will be uniform, the data can be used for research to better understand and detect interval breast cancer.
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