Updated on August 21, 2020

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Created on August 21, 2020

iBreastExam

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iBreastExam is a rapid diagnostic for early-stage detection of breast abnormalities.

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Product Description

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

$9,981.00

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.

Manufacturing/Building Method

The product is mass-manufactured in India.

Intellectural Property Type

Patent Protected

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.

Consumables

N

Detection sensitivity

83-86%

Indispensable equipment for function (Y/N)

N

Maintenance or calibration required by user at time of use? (Y/N)

N

Number of Tests Performed

Over 1,000

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Rechargeable battery

Time required for procedure (minutes)

<10 minutes

Design Specifications

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.

Technical Support

Provided by the manufacturer. Regional distributors also provide product servicing.

Replacement Components

There are no replaceable components.

Lifecycle

2-5 years

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.

Safety

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 StudyIndian 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 studyWorld J. Surg. Oncol., vol. 14, no. 1, p. 277, Oct. 2016, doi: 10.1186/s12957-016-1022-2.

Compliance with regulations

The iBreastExam has CE and Unicert ISO13485 certification and has been cleared by the FDA.

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