DermaSensor: World's first AI

The outcome is then presented to the user, indicating either "Investigate Further" or "Monitor." The former suggests that the patient should be referred to a dermatologist, while the latter implies no immediate need for specialist intervention.

“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,” said Cody Simmons, co-founder and CEO of DermaSensor. 

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,” added Simmons.

Encouraging values

A key factor in the FDA's decision was the performance of DermaSensor in a study published in November 2023 in JAAD International.

The study reported an observed sensitivity of 95.5 percent for detecting melanomas and a specificity of 32.5 percent. Despite the lower specificity, the positive and negative predictive values were encouraging at 16.0 percent and 98.1 percent, respectively.

In earlier clinical studies as well, DermaSensor exhibited a sensitivity of 94 percent for accurately classifying 338 high-risk lesions and a specificity of 23 percent for correctly identifying 1,681 low-risk lesions. 

Across ten study sites, the device demonstrated a 96% sensitivity for melanoma detection and a 91 percent sensitivity for high-risk melanocytic lesions.

“Achieving this medical milestone is a testament to the 12 years and tens of millions of dollars our company has invested in research and development to bring this powerful technology to market,” said Dr. Maurice Ferre, co-founder and chairman of DermaSensor.

The introductory pricing for the device for healthcare providers is $199 per month for up to five patients, and for those opting for unlimited usage, the price is $399 per month.