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Verisante Begins FDA Submission Process for Aura Device


NEW YORK (GenomeWeb News) – Verisante Technology said this week that it has begun submitting an application to the US Food and Drug Administration for 510(k) clearance of its Aura skin cancer detection device.

"Verisante has now submitted documents to the FDA as we begin the formal application process for approval to market and sell Aura in the US," CEO Thomas Braun said in a statement.

The Aura uses Raman spectroscopy to measure the levels of various biomarkers – including proteins, nucleic acids, and metabolites – in skin lesions to distinguish between benign and malignant lesions. By comparing the patterns of spectra generated by the device, clinicians can differentiate between the two.

The company has received for the device Health Canada approval, Australian Department of Health approval, and an EU CE mark for the device. It is also pursuing regulatory approval in Brazil and Mexico.

Verisante launched sales of the Aura in February 2013, placing an initial production run of 10 devices in Canada and Europe.