The first AI medical device capable of detecting all major skin cancers, DermaSensor, has just received FDA approval
The device can detect three of the most common types of skin cancer: melanoma, basal cell carcinoma, and squamous cell carcinoma.
In a study of more than 1,000 patients, DermaSensor demonstrated high sensitivity in detecting 224 cases of skin cancer, with a correct positive rate of 96%.
The DermaSensor, which looks similar to a smartphone with a pointed tip at the bottom, is used for non-invasive scanning of skin lesions. When the tip touches the skin, it projects light of different wavelengths that penetrate the skin and interact with cells.
Key features of DermaSensor:
1. Detection of skin cancer: capable of detecting the three most common types of skin cancer: melanoma, basal cell carcinoma, and squamous cell carcinoma.
2. Non-invasive scanning: Scanning skin lesions through the tip at the bottom of the device, using different wavelengths of light to interact with skin cells to detect cancer cells.
3. AI threat and risk assessment: After scanning, the device uses the built-in AI model to provide automatic threat and risk assessment, prompting the doctor to “investigate further” or “monitor”.
4. High sensitivity and specificity: According to clinical trials, DermaSensor has shown high sensitivity and specificity in the detection of skin cancer, enabling it to accurately identify skin cancer and reduce unnecessary biopsies.
5. Suitable for all skin types: Maintains consistent performance in patients with different skin types, making it an effective population-wide skin cancer screening tool.
The results of the FDA (US Food and Drug Administration) clinical study. Covering 22 research centers with a total of more than 1,000 patients, the purpose was to validate the performance of the DermaSensor device. Key findings and results include:
1. High sensitivity: In 224 cases of skin cancer, the DermaSensor device had a sensitivity of 96%. This means that the device is very accurate in identifying these cancer cases.
2. High specificity: When the device gives a negative result (i.e. it is judged to be non-cancerous), there is a 97% chance that it is indeed a benign lesion, which is true for all types of skin cancer.
3. Clinical Utility Study: In an additional study involving 108 physicians, the use of the DermaSensor device was found to reduce the proportion of missed skin cancers by half (from 18% to 9%). This suggests that the device can improve physicians’ accuracy and confidence in evaluating cancer lesions.
Detail:https://dermasensor.com
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