DermaSensor
DermaSensor Inc.DermaSensor is a handheld device combined with a base unit that uses optical spectroscopy and an AI/machine learning algorithm to analyze suspicious skin lesions and assist physicians, especially those not trained as dermatologists, in deciding whether a patient should be referred to a dermatologist. It provides a classification indicating whether to monitor the lesion or investigate further, helping clinicians detect common skin cancers earlier and more accurately.
Intended Use
The DermaSensor device is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above to assist in the decision regarding referral of the patient to a dermatologist.
Technology
The device consists of a handheld unit with a broadband light source and fiber-optic probe that transmits white light to the skin lesion and collects backscattered light, which is spectrally analyzed by a microspectrometer. A proprietary ML-derived classifier algorithm analyzes the spectral pattern via an internal microprocessor and returns a binary classification output at point of care.
Performance
Clinical performance testing including a pivotal multicenter study with 1,005 patients and 1,579 lesions demonstrated overall sensitivity of 95.5% for melanoma, SCC, and BCC, superior to primary care physicians. Specificity was lower (20.7%) but clinically acceptable. Multiple reader studies showed improved physician sensitivity with device aid. Non-clinical bench tests confirmed device safety, repeatability, biocompatibility, and software validation. Post-market surveillance is required for further validation especially in diverse skin phototypes.
Device Timeline
- 1
Submission
2/2/2023
11 months - 2
FDA Approval
1/12/2024
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