Breakthrough Designation Device
January 29, 2022
Sklip, Inc. is thrilled to announce that it has received a Breakthrough Designation Device status by the US Food and Drug Administration (FDA) for Sklip System AI. Sklip artificial intelligence is intended to provide skin cancer triage recommendations for medical professionals and health-conscious individuals about a concerning skin lesion – using a medical grade digital dermoscopy image.
What Is A Breakthrough Designation?
Breakthrough Device designation is a process designed to expedite the development and review of products that are intended to provide timely access to medical devices that lead to more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA determines the solution to be designated as a breakthrough device if it represents a breakthrough technology to which no approved/cleared alternative exists.
Why Does It Matter?
The Breakthrough Devices Program provides companies like Sklip, Inc. with the opportunity to connect with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase. In return, this can directly help the business receive feedback from the FDA and identify areas of agreement while having a prioritized review of their submission.
More About Sklip, Inc.
Sklip, Inc. is the only teledermoscopy company to be founded by practicing dermatologists Asst. Prof. Alexander Witkowski MD, PhD and Asst. Prof. Joanna Ludzik MD, PhD. – who both co-Direct the Skin Imaging and Technology Center at the Oregon Health and Sciences University in Portland, Oregon. Sklip is a global digital health company, medical marketing company and service provider with offices in the United States and Europe. Our technology empowers health care providers with medical grade tools for high definition digital dermoscopy imaging. Sklip has created the patent pend. universal clip-on smartphone dermatoscope – that requires no adapters – and developed an artificial intelligence solution for triage and earlier detection of skin cancers in collaboration with Prof. Giovanni Pellacani – President of the World Congress of Dermatology (since 2019).
What Is Next?
Working with top international leaders in dermoscopy and skin cancer triage, Sklip is collaborating with multiple academic centers through active clinical trials in the United States. This will be an essential pathway for the Company to further its mission to improve healthcare equity through democratization and “catch the inevitable, early.”