Diagnostic performance of the second-generation Wavelia microwave breast imaging system: a pilot clinical investigation - Summary - MDSpire

Diagnostic performance of the second-generation Wavelia microwave breast imaging system: a pilot clinical investigation

  • By

  • Eoin P Kerin

  • John P M O’Donnell

  • Sami M Abd Elwahab

  • Thomas O Butler

  • Luis Bouz Mkabaah

  • Angie Fasoula

  • Giannis Papatrechas

  • Petros Arvanitis

  • Luc Duchesne

  • Michael K Barry

  • Aoife J Lowery

  • Michael J Kerin

  • November 12, 2025

  • 0 min

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Objective:

To evaluate the lesion detectability of the Wavelia #2 Microwave Breast Imaging System in a clinical setting, with implications for improving breast cancer diagnosis.

Key Findings:
  • Lesions were detected in 56 out of 62 patients, yielding a sensitivity of 90% (95% c.i.: 80.5 to 95.5).
  • High sensitivity was maintained across various lesion subtypes and in young, pre-menopausal women with dense breasts.
  • All lesions ≤15 mm were accurately detected.
Interpretation:

Wavelia shows promise as an adjunct or alternative to current breast imaging modalities, particularly for high-risk populations with dense breast tissue, highlighting its potential impact on clinical practice.

Limitations:
  • The study was limited by a modest single-centre sample size, which may affect generalizability.
  • A high proportion of lesions marked with biopsy clips may have influenced detectability, introducing potential bias.
Conclusion:

Wavelia's high performance in detecting lesions in challenging cohorts suggests its potential to enhance breast cancer screening and diagnostics, warranting further multicentre trials to validate these findings.

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