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MediSpectra claims US market first for LUMA cervical imaging system

This article was originally published in Clinica

Executive Summary

MediSpectra has finally received US market approval for its LUMA cervical imaging system, which it claims is the first optical imaging device approved to help examine women with abnormal PAP smears. The company suffered a blow in May last year when an FDA advisory panel voted against the device's clearance, over concerns that clinical data failed to meet specified endpoints, and that detection rates were no better than biopsy.

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