Skin Cancer Detection, Simplified

The device has been tested and cleared by FDA for lesions between 2.5 to 15 mm in diameter. The device has not been tested on lesions smaller than 2.5 mm or larger than 15 mm, so it is not known if device performance differs for lesions those sizes.

Hold the tip perpendicular to the skin (at a 90° angle) and gently touch the lesion surface, resulting in a slight indentation in the skin. The device tip pressure should be similar to that of a marking pen.

Before use with each patient, the handheld unit must be placed in the base to complete an automatic calibration process. This calibration step only occurs once per patient, after which the device can be used on up to five lesions.

“Monitor” indicates that the lesion’s spectral pattern is consistent with benign characteristics. No spectral score is shown. In the FDA pivotal study of over 200 skin cancers, the likelihood of the lesion being benign (i.e. the Negative Predictive Value or NPV) was 97% across all three skin cancers. Clinicians should continue routine observation and apply clinical judgment.

A spectral score ranging from 1 to 10 is displayed only when the result is “Investigate Further.” Higher scores indicate an increase in similarity between the lesion and malignant characteristics. In the FDA pivotal study of over 200 skin cancers, the likelihood of cancer ranged from 6% for a score of 1 to 61% for a score of 10.

The device is intended for use by physicians that are not already specialized in the diagnosis and management of suspicious lesions. While various studies have been conducted in both the dermatology and primary care settings, the benefit-risk of the device was evaluated and cleared for use by the FDA for physicians without specialized training in dermatology. The FDA also required a human factors study that successfully demonstrated that different non-physician clinical staff could understand the device instructions and operate the device.

Yes, practices receive free access to e-learning courses designed for clinicians and staff to support training, onboarding, and continuing education.

The system includes a charging dock, power supply, and regional power adapter blades.

Assessment results are displayed immediately on the device to aid in clinical decision making. Additionally, device results are recorded and accessible through the secure Customer Portal by credentialed users in the physician practice.