Medical Device Network

Enspectra’s VIO System secures FDA 510(k) clearance

The non-invasive VIO System can produce real-time, multispectral images of the skin within seconds.

Enspectra Health has received FDA 510(k) clearance from the US Food and Drug Administration (FDA) for VIO System, a non-invasive skin imaging technology.

By combining reflectance confocal and multiphoton laser scanning microscopy, the VIO System can produce real-time, multispectral images of the skin within seconds.

Enspectra Health CEO and co-founder Gabriel Sanchez said: “This is the first multiphoton imaging modality to ever be cleared by the FDA. This significant achievement is the result of the excellent work of the Enspectra Health team and our clinical advisers.

“Our submission was cleared by the FDA ahead of plan, underscoring our ability to successfully drive an innovative technology from concept to clearance.”

Designed for use by dermatologists or pathologists trained in skin histology, the handheld device digitises pathology directly from the patient's skin, providing clinical insights for physicians.

Enspectra said the technology enables vivo imaging of various skin components, such as blood vessels, collagen, stratum corneum, pigment, hair shafts or follicles, solar elastosis, hyperkeratosis, atypia, and epidermal disarray, aiding physicians in clinical diagnosis.

The VIO System was assessed in the VISTA US Pivotal Study, a prospective, multicentre clinical trial.

During the clinical study, physicians could identify skin features on VIO images with more than 90% average accuracy, surpassing the study's endpoints.

Enspectra plans to initially offer the VIO System to a limited number of clinical partners.

The company also intends to seek approval for additional indications and to continue the development of its artificial intelligence (AI)/ machine learning (ML) clinical decision support algorithms.

Manu Jain from Memorial Sloan Kettering said: “The VIO System has tremendous potential for evaluating skin in clinical practice.

“The cross-sectional images from VIO can be used to inform clinical decision-making in a variety of dermatological conditions in real-time, which can have a powerful impact on clinical workflow and the patient journey.”