The FDA has greenlit DermaSensor, marking the maiden voyage of an AI-powered medical device aimed at aiding healthcare providers in identifying prevalent skin cancer types. Unlike a broad screening tool, DermaSensor zooms in on lesions previously flagged as suspicious, offering a closer inspection to healthcare professionals. Solely available via prescription for healthcare provider use, it isn’t intended for public or home use.
Armed with an AI algorithm, DermaSensor, a wireless handheld device, scrutinizes the appearance of suspicious skin lesions, providing insights into subsequent actions for providers. The device’s advent is expected to empower around 300,000 primary care providers in the U.S. to administer point-of-care diagnostic tests for common skin cancers, potentially expediting access to necessary care.
The device fills a void in primary care, where evaluation of suspicious moles has traditionally relied on subjective judgment and clinical training. Michele Green, MD, a cosmetic dermatologist at Northwell Lenox Hill Hospital, likened DermaSensor to a flashlight for non-specialist healthcare providers, enabling them to refer patients to dermatologists when warranted.
Utilizing elastic scattering spectroscopy, the device illuminates the skin lesion, revealing cellular structures beyond the naked eye’s reach. The process involves:
- Identifying a potentially cancerous skin lesion.
- Positioning the device against the lesion.
- Scanning the lesion and collecting recordings.
- DermaSensor’s AI algorithm analyses spectral data and provides results within seconds.
A “Further Investigation” result prompts referral to a specialist, while a “Monitor” indicates no immediate need for specialist intervention. Not a standalone diagnostic tool, DermaSensor complements clinical assessments by healthcare providers.
In FDA trials encompassing 1,000+ patients, DermaSensor demonstrated 96% sensitivity across 224 skin cancers. It can detect common skin cancers—melanoma, basal cell carcinoma, or squamous cell carcinoma—in individuals aged 40 and above. However, it isn’t tailored to identify rare skin cancer types like Merkel cell carcinoma, sebaceous carcinoma, and Kaposi’s sarcoma, as explained by Ariel Ostad, MD, a dermatologist and cosmetic surgeon in New York City.
