FDA Clearance Granted for First AI-Powered Medical Device that can detect common Skin Cancers like Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma.
DermaSensor : AI-Powered Medical Device to detect Skin Cancers
Revolutionizing Skin Cancer Detection: FDA Clears Breakthrough AI-Powered Handheld Device. It is now available to Improve Skin Cancer Detection in Primary Care.
DermaSensor Inc. is a health technology firm dedicated to creating non-invasive instruments that enhance the capabilities of primary care physicians in detecting skin cancer. The DermaSensor device, an economical handheld tool, employs spectroscopy and advanced algorithms to swiftly assess skin lesions for potential cancer. With an FDA clearance and CE marking, the DermaSensor device is currently accessible for purchase in the United States, aligning with DermaSensor’s goal of ensuring widespread access to efficient skin cancer screenings.
FDA clearance
In a groundbreaking development, DermaSensor Inc. has received FDA clearance for its innovative real-time, non-invasive skin cancer evaluation system. This marks a significant milestone, as the 300,000 primary care physicians across the U.S. can now have access to a quantitative, point-of-care testing solution for all types of skin cancer. The goal is to enhance the identification of skin cancer in primary care settings, thereby expediting patient access to crucial care.
Skin cancer
Statistics reveal that one in five Americans will experience some form of skin cancer by the age of 70, leading to an annual treatment cost of $8.1 billion in the U.S. With an estimated 5.5 million new cases annually, early detection is crucial. Fortunately, 99 percent of skin cancers, including the deadliest form, melanoma, are curable if identified early. However, challenges in accessing dermatology services, especially in rural areas, make empowering primary care physicians to identify potential cases even more vital.
How does DermaSensor’s AI-powered spectroscopy technology work in detecting Skin Cancers ?
Primary care physicians play a pivotal role in healthcare delivery, addressing diverse medical concerns and contributing significantly to the early detection of diseases. Traditionally, physicians relied on naked eye examinations or magnified visual inspections for evaluating suspicious moles, both subjective and dependent on clinical training. Now, DermaSensor’s AI-powered spectroscopy technology allows physicians to non-invasively evaluate cellular and subcellular characteristics of questionable lesions for skin cancer. The handheld device provides an immediate, objective result using an FDA-cleared algorithm.
Cody Simmons, co-founder and CEO of DermaSensor, emphasized the role of artificial intelligence in healthcare’s golden age, pairing advanced capabilities with novel technologies like spectroscopy to optimize disease detection and care. DermaSensor’s device, the first FDA-cleared tool providing primary care physicians with an automated evaluation for suspicious lesions, addresses a longstanding unmet need in medicine.
Clinical pivotal study
The FDA pivotal study, led by the Mayo Clinic across 22 study centers and involving over 1,000 patients, validated the device’s performance, demonstrating a remarkable 96 percent sensitivity across all 224 skin cancers. Furthermore, a negative result had a 97 percent chance of being benign for all skin cancers. In a companion clinical utility study with 108 physicians, the DermaSensor device reduced missed skin cancer cases by half, increasing physicians’ accuracy and confidence in assessing cancerous lesions.
The benefits extend beyond primary care physicians to dermatologists, fostering improved collaboration and enabling better-prioritized referrals. Having conducted 13 clinical studies in the last decade, six of which supported FDA clearance, DermaSensor’s breakthrough is a result of 12 years and tens of millions of dollars invested in research and development.
Summary
Dr. Maurice Ferre, co-founder and chairman of DermaSensor, expressed gratitude to the FDA for their collaboration, marking this achievement as a medical milestone. With FDA clearance for their Breakthrough Designated De Novo submission, DermaSensor is set to transform skin cancer detection, providing an affordable, handheld tool for effective and accessible skin cancer checks. The DermaSensor device is currently FDA-Cleared, CE-Marked, and available for sale in the U.S.
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