Sklip Inc. is excited to officially announce that it has received a Breakthrough Designation Device status by the US Food and Drug Administration (FDA). Sklip System AI is a tool that uses Artificial Intelligence technology to increase the early detection of skin cancers.
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The FDA’s Breakthrough Devices Program enables new, innovative technology to be reviewed in an expedited process, since the technology would enable a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. Sklip Inc. is now beginning clinical trials at an academic health center in the U.S. to further test this technology in real world settings.
Statistics show that skin cancer is an increasing public health concern:
- 1 in 5 Americans will develop skin cancer by the age of 70.
- More than 2 people die of skin cancer in the U.S. every hour.
- When detected early, the 5-year survival rate for melanoma is 99 percent.
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The Sklip dermatoscope hardware uses patent pending technology to attach to your smartphone or tablet without the need for an adapter. When aligned with your phone’s camera, the attachment allows the user to take high-definition images of moles. Sklip System AI software enables automatic triage of skin lesions using an algorithm to determine if a lesion has features suspicious for skin cancer. Sklip can be used to supplement in-office skin exams by licensed medical professionals (MD, DO, NP, PA), improve virtual dermatology care and allow health-conscious individuals to identify concerns accurately from the convenience of home.
The company was founded by dermatologists and skin cancer experts Alexander Witkowski MD, PhD and Joanna Ludzik MD, PhD who built the Sklip team with a common belief in healthcare for everyone through improved access and lowered costs. Their work aims to fix the fractured American healthcare system with innovative tools and technology.
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