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.
Market Suggested Retail Price
Distributors / Implementing Organizations
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.
The product is mass-manufactured in India.
Intellectural Property Type
User Provision Model
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.
Distributions to Date Status
As of July 2020, 200+ products have been installed in health care settings and 300,000+ women have been screened.
Indispensable equipment for function (Y/N)
Maintenance or calibration required by user at time of use? (Y/N)
Number of Tests Performed
Power supply type: Continuous, Recharging only (V, time required, battery life), Other
Time required for procedure (minutes)
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 Parameters
Manufacturer specified performance targets include portability, low cost, scalable, standardized, accessible, and easy to use.
Vetted Performance Status
There have been three clinical studies using the iBreastExam which showed the following approximate averages: 86% sensitivity, 90% specificity, 63% PPV, 89% NPV.
Device safety training is included in the general device training provided to health care workers.
Complementary Technical Systems
A smartphone is required for data transmission and saving. A reliable power source is required to recharge the battery in the device.
Academic Research and References
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.
Compliance with regulations