iBreastExam is a rapid diagnostic for early-stage detection of breast abnormalities.
iBreastExam is a low cost, battery-powered, handheld rapid diagnostic device used for the identification of breast abnormalities and early detection of breast cancer. The device is radiation-free and is non-invasive. The product is being commercially distributed in over 25 countries across Africa and South Asia.
The product is currently commercially available in Mexico, Nepal, Oman, Indonesia, India, Myanmar, and Botswana, and will be available in more African and South Asian countries in the future.
GE Healthcare is the primary distributor. iBreastExam has partnered with 40+ private clinics, governmental institutions, non-profits, and corporate social responsibility initiatives to enable the use of the product and breast examinations.
A primary competitor of this product is the Pink Drive, a mobile breast check service. The additional technological competition includes mammograms, ultrasounds, x-ray, and physical examination.
Goal 3: Good health and well-being
Health care workers at primary care locations such as a doctor’s clinic, community health centers, health camps, or a hospital’s out-patient department.
The product is mass-manufactured in India.
As of now, the product has been used through large-scale governmental initiatives as partnerships between the manufacturer and governmental, national, or international institutions. Users can request a demo through the manufacturer’s website.
As of July 2020, 200+ products have been installed in health care settings and 300,000+ women have been screened.
The iBreastExam is a handheld device for breast abnormality detection. The device uses a ceramic sensor technology that is able to detect subtle variations in tissue elasticity, which corresponds to the detection of lumps in the breast tissue. The device is battery operated, wireless, and radiation-free. A typical scan takes about 5 minutes and the data from the device is immediately sent to a smartphone, where user data is stored. The device goes over the four quadrants of the breast during an exam and colours are used to communicate possible abnormalities to the operator. Green represents normal tissue and red indicates a possible abnormality and need for further assessment. The colours are shown both by an LED on the device itself as well as on a breast map on the smartphone. The device can detect tissue abnormalities as small as 3-5 mm.
It takes 4-8 hours to train a health care worker on the operation of the device, after which the worker takes a test before being certified.
There are no replaceable components.
Manufacturer specified performance targets include portability, low cost, scalable, standardized, accessible, and easy to use.
There have been three clinical studies using the iBreastExam which showed the following approximate averages: 86% sensitivity, 90% specificity, 63% PPV, 89% NPV.
No third-party organizations, only testing performed by the designer.
Device safety training is included in the general device training provided to health care workers.
A smartphone is required for data transmission and saving. A reliable power source is required to recharge the battery in the device.
S. P. Somashekhar, R. Vijay, R. Ananthasivan, and G. Prasanna, Noninvasive and Low-Cost Technique for Early Detection of Clinically Relevant Breast Lesions Using a Handheld Point-of-Care Medical Device (iBreastExam): Prospective Three-Arm Triple-Blinded Comparative Study, Indian J. Gynecol. Oncol., vol. 14, no. 2, pp. 1–6, Jun. 2016, doi: 10.1007/s40944-016-0057-1.
R. B. Broach, R. Geha, B. S. Englander, L. DeLaCruz, H. Thrash, and A. D. Brooks, A cost-effective handheld breast scanner for use in low-resource environments: A validation study, World J. Surg. Oncol., vol. 14, no. 1, p. 277, Oct. 2016, doi: 10.1186/s12957-016-1022-2.
The device has been evaluated through three clinical trials and has been evaluated against current standard breast examination techniques including mammogram, clinical breast exam, and ultrasound.
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