Evaluation of the Second-Generation Wavelia Microwave Imaging System for Breast Diagnosis

Overview

The Wavelia #2 microwave breast imaging system demonstrated a 90% sensitivity in detecting breast lesions, surpassing the predefined 75% threshold in a prospective pilot study. It showed consistent high performance across lesion subtypes, breast densities, and age groups, including younger and pre-menopausal women.

Background

Mammographic screening has improved breast cancer outcomes but has limitations, especially in detecting invasive lobular carcinoma and in women with dense breasts or younger age. Alternative imaging modalities like ultrasound and MRI have their own constraints. Microwave breast imaging (MWBI) offers a non-compressive, radiation-free option that may complement existing techniques. The Wavelia #2 system is a second-generation MWBI device designed to accommodate a wide range of breast sizes and improve lesion detectability.

Data Highlights

Key Findings

• Wavelia detected lesions in 56 out of 62 patients, achieving 90% sensitivity.
• High lesion detectability was maintained across benign and malignant subtypes.
• Performance was robust in younger, pre-menopausal women and those with dense or extremely dense breasts.
• All lesions measuring 15 mm or less were accurately detected.
• Sensitivity was unaffected by the presence of biopsy clips.
• The system combines AI-assisted semi-automated lesion detection with radiologist interpretation using true volumetric 3D imaging.

Clinical Implications

Wavelia's high sensitivity in dense breast tissue and younger women addresses key limitations of mammography and ultrasound, potentially improving early detection in high-risk groups. Its non-compressive, radiation-free design may enhance patient comfort and screening uptake. Integration of AI with radiologist expertise offers a promising diagnostic pathway that could complement or partially replace current imaging modalities.

Conclusion

The Wavelia #2 microwave imaging system shows promising preliminary results as a sensitive, non-invasive adjunct for breast lesion detection across diverse patient subgroups. Larger multicentre studies are needed to validate these findings and define its role in clinical practice.

References

1. University Hospital Galway Study 2023-2024 -- Evaluation of the Second-Generation Wavelia Microwave Imaging System for Breast Diagnosis