FDA Approval: AI Device to Aid Doctors in Identifying Suspicious Moles for Skin Cancer – DermaSensor

The Food and Drug Administration (FDA) has granted approval for the inaugural artificial intelligence-driven medical device designed to assist physicians in identifying the prevalent types of skin cancer in patients.
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The Food and Drug Administration (FDA) has granted approval for the inaugural artificial intelligence-driven medical device designed to assist physicians in identifying the prevalent types of skin cancer in patients. 

Developed by DermaSensor, a medical device company based in Miami, the technology is intended for the additional assessment of lesions previously identified by doctors as suspicious and is not intended for use as a primary screening tool.

DermaSensor: AI for Deep Lesion Analysis

FDA-Approval-AI-Device-To-Aid-Doctors-In-Identifying-Suspicious-Moles-For-SKin-Cancer-DermaSensor
The Food and Drug Administration (FDA) has granted approval for the inaugural artificial intelligence-driven medical device designed to assist physicians in identifying the prevalent types of skin cancer in patients.

More precisely, the handheld device, known as DermaSensor, employs AI-powered spectroscopy technology for the analysis of cellular and subcutaneous characteristics of lesions on patients. 

This non-invasive device offers real-time results by utilizing an AI algorithm trained on data encompassing over 4,000 malignant and benign lesions, as indicated by the company. 

It provides a “spectral similarity score” by comparing the assessed lesion to known cases, aiming to complement a physician’s evaluation of a mole or lesion. 

DermaSensor posits that this technology provides primary care physicians, dermatologists, and other medical professionals with a sophisticated means of assessing moles for skin cancer beyond traditional visual examination or magnification.

How Does DermaSensor Work?

Here is the operational process of DermaSensor, as outlined by the company:

  • A physician identifies a potentially cancerous lesion on a patient.
  • The wireless device is applied to the lesion to capture data.
  • DermaSensor conducts a thorough scan of the lesion.
  • A proprietary algorithm analyzes spectral data and promptly provides an assessment.
  • An “Investigate Further” result indicates that a specialist should review the lesion.
  • A “Monitor” result suggests that no immediate further evaluation is required.

Cody Simmons, the co-founder and CEO of DermaSensor, stated in an announcement of FDA clearance, “We are entering the golden age of predictive and generative artificial intelligence in healthcare, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care.”

Furthermore, the device is not only designed to identify melanoma, the most fatal type of skin cancer, but it can also evaluate moles for basal cell carcinoma and squamous cell carcinoma.

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