Breast Tumor Localization

Abstract

Existing market solutions for breast lesion localization primarily rely on invasive devices, which can cause considerable patient discomfort and raise safety concerns among healthcare providers. These invasive options often require multiple clinic visits and involve procedures that are inconvenient and, sometimes, distressing for patients. Our solution proposes a non-invasive device that uses a controlled magnetic field to create detectable signals in biopsy markers, allowing for precise localization without the need for invasive procedures. This enables precise localization without the need for invasive procedures, offering a safer and more comfortable alternative that reduces patient discomfort and minimizes the need for repeat visits. For healthcare providers, the device is designed to be user-friendly, requiring minimal training while delivering high accuracy in targeting biopsy markers. However, in order to enter the market, the device must achieve 510(k) clearance, classifying it as a Class II medical device. The device specifications include a magnetic-based handheld probe that uses a solenoid coil to create a magnetic field, enabling accurate localization of magseed and other biopsy markers. The device’s circuit allows current to flow through the coil, generating a magnetic field that channels frequency into a cylindrical probe tip for marker detection. In terms of manufacturing, the estimated market price for the handheld probe is set at $20,000, reflecting both manufacturing and materials costs. This pricing aims to balance accessibility for healthcare providers with a sustainable return on investment, ensuring the device’s competitiveness in the medical device market. By addressing both patient and clinician needs, our device represents a significant advancement in biopsy marker localization technology, paving the way for a safer and more comfortable standard of care.

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