Miami-based device maker DermaSensor announced on Wednesday that the FDA has cleared its handheld device that utilizes artificial intelligence (AI) to detect skin cancer non-invasively. Physicians can use the device to take spectral recordings of suspicious skin lesions, which are then analyzed by an AI algorithm to provide immediate results. The device is capable of detecting all three common types of skin cancer—basal cell carcinoma, squamous cell carcinoma, and melanoma—and signals to physicians whether further investigation is necessary.
The FDA authorized marketing for the device last week, with the caveat that it should be used on lesions already flagged as suspicious and not be the sole diagnostic criterion. In addition, the FDA has mandated that DermaSensor conduct additional post-market clinical validation performance testing across different demographic groups.
The DermaSensor device will be available through a subscription model, priced at $199 per month for five patients or $399 per month for unlimited use. This pricing structure aims to make the device accessible to a wide range of healthcare providers.
Previous studies have shown promising results for DermaSensor, with a sensitivity rate of 96% across all 224 forms of skin cancer and different skin types. Another study revealed that the device reduced missed skin cancer diagnoses by half in a clinical cohort of 108 physicians.
The development of AI-driven medical devices like DermaSensor is part of the ongoing innovation in the medical field. Other companies, such as Google, are also exploring the integration of AI in healthcare, with plans to develop an AI-powered chatbot capable of conducting medical interviews and making diagnoses.
DermaSensor invested $25 million in the research and development of its device. The company's achievement in gaining FDA clearance highlights the potential of AI in improving the accuracy and efficiency of skin cancer detection.
In conclusion, the FDA's clearance of DermaSensor's AI-powered skin cancer detection device marks a significant advancement in non-invasive diagnostic tools. The device's ability to detect multiple types of skin cancer and its potential to reduce missed diagnoses demonstrate its potential impact on healthcare. However, further clinical validation testing and real-world application will be needed to fully assess the device's effectiveness and integration into medical practice.