Clinical Scorecard: Evaluation of the Second-Generation Wavelia Microwave Imaging System for Breast Diagnosis: A Preliminary Clinical Study

At a Glance

Key Highlights

• Wavelia #2 MWBI system demonstrated 90% sensitivity in lesion detection, exceeding the 75% predefined threshold.
• High lesion detectability was consistent across lesion subtypes, breast densities, and age groups including young and pre-menopausal women.
• The system provides non-compressive, radiation-free imaging with interpretable 3D volumetric images combining AI and radiologist expertise.

Guideline-Based Recommendations

Diagnosis

• Consider Wavelia MWBI as an adjunct or alternative imaging modality especially in dense-breast and younger women where mammography sensitivity is limited.
• Use Wavelia imaging alongside standard-of-care work-up for symptomatic breast abnormalities.

Management

• Incorporate Wavelia imaging to improve lesion detection accuracy in challenging anatomical and high-risk subgroups.
• Leverage AI-assisted semi-automated lesion detection combined with radiologist interpretation for diagnostic decisions.

Monitoring & Follow-up

• Monitor lesion detectability across patient subgroups including age, breast density, and lesion type to assess imaging performance.
• Evaluate imaging outcomes in multicentre trials to validate broader clinical utility.

Risks

• No safety concerns reported; Wavelia is radiation-free and non-compressive, minimizing patient discomfort and risk.
• Potential confounding by biopsy clips present prior to imaging should be considered in interpretation.

Patient & Prescribing Data

Women presenting with discrete breast abnormalities, including those with dense breasts and younger age groups

Wavelia MWBI shows high sensitivity for lesion detection, particularly effective in populations where mammography sensitivity is reduced, supporting its use as a complementary diagnostic tool.

Clinical Best Practices

• Employ Wavelia MWBI in symptomatic breast units to enhance lesion detection especially in dense-breast and younger women.
• Combine AI semi-automated lesion detection with radiologist expertise for accurate interpretation of volumetric 3D images.
• Use Wavelia as a non-compressive, radiation-free alternative to improve patient comfort and screening uptake.
• Validate findings through larger multicentre studies to confirm generalizability and performance across diverse populations.

References

• Clinical trial registration NCT05757427