iBreastExam

Target SDGs

Market Suggested Retail Price

$10,000.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

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.

Competitive Landscape

Direct competitors include BreastIT.

Manufacturing/Building Method

The product is mass-manufactured in India.

Intellectural Property Type

Patent

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.

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.

Product Schematics

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

Compliance with regulations

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

Evaluation methods

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.

Other Information

The iBreastExam has won several awards: 2019 Lyfebulb-Helsinn Oncology Innovation Award, 2019 Best Pitch Innov8 Talks Arab Health Award, 2018 Bayer Foundation Grants 4 Impact Award.