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LifeSpex developing tissue spectroscopy technology for cervical cancer detection.

This article was originally published in The Gray Sheet

Executive Summary

LIFESPEX PMA SUBMISSION FOR SPECTROSCOPY-BASED PAP SMEAR ALTERNATIVE is expected in 18 to 24 months, the Houston-based startup says. The firm estimates a premarket approval application could be ready for submission to FDA within two years for a device using tissue spectroscopy to screen and/or diagnose cancerous and precancerous lesions of the cervix. LifeSpex has no immediate plans to submit an investigational device exemption to the agency and still is in the process of deciding whether to pursue a screening or diagnostic indication.
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