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Guided Therapeutics files LightTouch scanner PMA with FDA

Guided Therapeutics has filed premarket approval application (PMA) for the LightTouch cervical scanner with the US Food and Drug Administration (FDA) for patients at risk of cervical cancer.

The LightTouch, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively.

Unlike Pap or HPV tests, the LightTouch test does not require laboratory analysis or a tissue sample and provides results immediately and eliminate costly unnecessary testing, Guided Therapeutics said.

Guided Therapeutics claims that in a multi-center FDA-approved pivotal trial, the device found cervical disease up to two years earlier than with current standard-of-care screening and diagnostic techniques.

Guided Therapeutics president and CEO Mark Faupel said that if approved by the FDA, LightTouch offers the potential to improve healthcare for women, by finding disease earlier, when it is most effectively treated, and to lower healthcare costs by streamlining the diagnostic process.

“Beyond the LightTouch, we intend to bring additional non-invasive, point-of-care products to market based on our platform technology,” Faupel said.