Sklip Inc. has announced that the US Food and Drug Administration (FDA) has granted its AI dermatoscope tool the Breakthrough Designation Device status. Sklip System AI is a tool that uses AI technology to detect early signs of skin cancers.
The Sklip dermatoscope device uses patent-pending technology to manually attach to smartphone or tablet without the need for an adapter. When aligned with the phone camera, the device allows the user to take HD images of their moles. Sklip dermatoscope AI software enables automatic triage of skin lesions using an algorithm and determines if a lesion has signs of skin cancer.
Sklip can be used for in-office skin exams by licensed medical professionals to improve virtual dermatology care. It can also be used to allow health-conscious individuals to identify conditions accurately from the convenience of home.
The Breakthrough Devices Program of the FDA reviews innovative technologies in an expedited process. These are the technologies that would allow effective treatment of life-threatening and irreversibly debilitating human conditions.
The company will begin clinical trials at academic health centers in the US to further test this technology in real-world settings.
Skilp Inc. was founded by dermatologists and skin cancer experts Alexander Witkowski and Joanna Ludzik to facilitate improved healthcare access at lowered costs with innovative tools and technology.