FDA Clears DermaSensor Device for Skin Cancer Detection

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The US Food and Drug Administration (FDA) on Wednesday authorized for marketing a new hand-held device for skin cancer detection. DermaSensor is intended to detect melanoma, basal cell carcinoma, and squamous cell carcinoma.

The company that produces the device, also called DermaSensor, announced the news in a press release on Wednesday.¹

An AI-powered device intended for use by primary care physicians (PCPs), DermaSensor uses elastic scattering spectroscopy (ESS) to evaluate the cellular and subcellular characteristics of suspicious skin lesions, according to the company.

The device collects 5 spectral recordings from a lesion in 1 scan, and these data are evaluated using an algorithm. This algorithm was developed and validated on more than 20,000 scans, according to the company.

After lesion evaluation, device users are presented with a result of either “Investigate Further,” meaning the PCP should refer the patient to a dermatologist, or “Monitor,” meaning there is no immediate need for a specialist referral.

In a multicenter, prospective blinded study published in November 2023 in JAAD International, DermaSensor’s observed sensitivity was 95.5% (95% CI, 84.5%-98.8%, 42 of 44 melanomas), and observed specificity was 32.5% (95% CI, 27.2%-38.3%). The positive and negative predictive values were 16.0% and 98.1%, respectively.²

“This pivotal study and the corresponding clinical utility studies were all conducted with non-specialists to demonstrate the device performance and corresponding benefit to PCPs, since the device is intended to benefit non-specialists in their lesion evaluation and management, in accordance with the indications for use cleared by the FDA,” Cody Simmons, co-founder and chief executive officer of DermaSensor, told Dermatology Times.

In earlier clinical studies, known as DERM-ASSESS III and DERM-SUCCESS, the device demonstrated a sensitivity of 94% for correctly classifying 338 high-risk lesions and a specificity of 23% for correctly classifying 1,681 low-risk lesions.³ Ten study sites reported the device had a 96% sensitivity for melanoma detection and a 91% sensitivity for high-risk melanocytic lesions.

The device was found to have "similar sensitivity and overall accuracy as the in-person, dermatologist study investigators,” according to Simmons. It received 2021 FDA Breakthrough Designation based on these studies.

“Equipping PCPs, the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine,” Simmons said in the Wednesday press release.

“While dozens of companies have attempted to address this problem in recent decades, we are honored to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions.”

The introductory pricing for the device is $199 per month for 5 patients per month, or $399 per month for unlimited use.

Editor's note: What do you think of AI devices like this? Share your thoughts with DTEditor@mmhgroup.com.

References

1. FDA clearance granted for first AI-powered medical device to detect all three common skin cancers (melanoma, basal cell carcinoma and squamous cell carcinoma). News release. DermaSensor. January 17, 2024. Accessed January 17, 2024. https://www.dermasensor.com/fda-clearance-granted-for-first-ai-powered-medical-device-to-detect-all-three-common-skin-cancers-melanoma-basal-cell-carcinoma-and-squamous-cell-carcinoma/.

2. Hartman R, Trepanowsk N, Chang MS, et al. Multicenter prospective blinded melanoma detection study with a handheld elastic scattering spectroscopy device. JAAD International. 2023. ISSN 2666-3287. https://doi.org/10.1016/j.jdin.2023.10.011.

3. Andrus E. Skin cancer detection device backed by studies. Dermatology Times. https://www.dermatologytimes.com/view/skin-cancer-detection-device-backed-by-studies. Accessed January 17, 2024.