FDA Awards Breakthrough Device Designation to AI Platform for Classifying Skin Cancer


The VIO Skin Platform by Enspectra Health was designed to assess lesions indicating either basal cell carcinoma or squamous cell carcinoma.

An announcement by Enspectra Health, a company known for its focus on health technology, indicated that the US Food and Drug Administration (FDA) awarded a Breakthrough Device Designation to Enspectra’s advanced artificial intelligence (AI)-powered ‘VIO Skin Platform’ (VIO).1

The company’s AI platform was designed with the purpose of assessing lesions that could indicate the presence of squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) among individuals deemed to be high-risk. These prevalent forms of skin cancer remain an issue for many such patients and early identification can be crucial, especially given the reported delays in screening appointments that have occurred in the years following the COVID-19 lockdowns.2

"When identified early, appropriate treatment can be delivered for non-melanoma skin cancer," Sarah T. Arron, MD, PhD, board-certified dermatologist & Mohs surgeon and clinical advisor to Enspectra Health, said in a statement. "Early intervention aids in the prevention of cancer recurrence and spread."1

SCC and BCC are known to be the most prevalent forms of skin cancer within the US, with almost all cases of non-melanoma skin cancer (NMSC) being either SCC or BCC. While both forms often result in a lower risk of mortality among patients compared to melanoma, individuals who are deemed to be at high-risk are also more likely to have disease progression. This results in a greater risk of morbidity as well as mortality.

The new AI platform awarded this designation by the FDA involved a combination of the previously FDA-cleared VIO technology with a function known as VIO.ai NMSC. This is a software function for Computer-Aided Diagnosis and Triage (CADx/CADt) which is designed to assist clinicians in their work involving the identification of different types of lesions, thereby supporting their clinical determinations.

The FDA’s Breakthrough Devices Program is formed for the purposes of promoting pioneering medical technology designed to improve the diagnosis and/or treatment of dangerous or irreversibly debilitating conditions. Their program is designed to expedite the processes of development, assessment, and approval to allow for future patients to get more swift access to such advanced medical devices.

Quicker access to such life-saving technologies may allow for more impactful and improved treatments compared to options available currently.

"Attaining breakthrough designation for our next generation technology underscores the need for a non-invasive assessment option in non-melanoma skin cancer," Gabriel Sanchez, PhD, CEO and co-founder of Enspectra, said in a statement. "We are honored to work closely with the FDA to bring advanced AI/ML tools to dermatology for better patient care."


  1. Enspectra Health Receives FDA Breakthrough Device Designation for AI-powered Imaging Platform Targeting Skin Cancer. Enspectra Health. June 5, 2024. https://www.prnewswire.com/news-releases/enspectra-health-receives-fda-breakthrough-device-designation-for-ai-powered-imaging-platform-targeting-skin-cancer-302164119.html. Date accessed: June 5, 2024.
  2. Smith T. Melanoma Screening Delays During Lockdowns Linked to Deaths, Significant Economic Cost. HCPLive. February 28, 2024. https://www.hcplive.com/view/melanoma-screening-delays-during-lockdowns-linked-to-deaths-significant-economic-cost. Date accessed: June 5, 2024.
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