Currently, Nevisense is the only FDA-approved melanoma diagnostic support device in the US, using Electrical Impedance Spectrometry, powered by AI, to provide objective data to assess the probability of melanoma based on cellular patterns within the lesion.

The FDA held a meeting with the Medical Devices Advisory Committee in late July to gather expert advice on the regulation of AI driven, skin lesion analyzers (SLAs) and Apps for skin cancer detection. Panel members urged caution for skin cancer detection SLAs and Apps and stressed the need for more high quality research to validate these technologies.

“The standards would have to be set very high for new products, especially those intended for consumers,” said FDA panelist Murad Alam, MD, a dermatologist from Northwestern University, Chicago.

The panel considered the FDA’s proposal to change the classification status of Nevisense and any new products that assist dermatologists in melanoma detection from the most stringent regulatory category, class III, to the less restrictive class II. The Panel underscored the potential risks of reclassifying these technologies and strongly recommended keeping them in the class III category. SciBase Holding AB, a developer of augmented intelligence-based solutions for skin disorders, reports that they shared the same opinion as panel experts through written submissions and oral presentations. SciBase believes the current process where FDA sets very high standards and is closely involved in clinical validation study design is the most appropriate.

“We very much agree with the Panel’s recommendation. Nevisense is currently the only SLA available on the market and we have gone through the very rigorous Class III PMA (Pre Market Approval) process with it’s extremely high safety demands. Reclassifying this type of product to Class II would reduce the level of FDA oversight for new products entering into this space; something we believe could potentially compromise patient safety. While the FDA is not legally bound to follow the Panel’s recommendation, we believe that such an overwhelming recommendation will be difficult for the FDA to ignore. A final decision from FDA could take months or years, though it is our belief that even in the medium term a decision would not practically affect Nevisense or the market itself as stringent requirements on clinical study data would still apply," says Simon Grant,  CEO SciBase, in a news release.