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11th January 2024

Enspectra Health Achieve FDA Clearance: Breakthrough VIO System

Enspectra Health, a pioneering health tech company, celebrates FDA 510(k) clearance for the groundbreaking VIO System. Unleashing a new era in noninvasive imaging, VIO integrates reflectance confocal and multiphoton microscopy for swift, high-resolution skin imaging.

FDA-Cleared! Groundbreaking VIO system

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Enspectra Health, a leading health tech company, has proudly announced the receipt of US FDA 510(k) clearance for its revolutionary VIO System, marking the dawn of a new age in noninvasive imaging. 

Representing a paradigm shift in technology, VIO integrates reflectance confocal and multiphoton microscopy, allowing for rapid cellular-resolution, cross-sectional imaging of the skin within seconds. The handheld and easily portable VIO System digitizes pathology directly from the patient’s skin, providing physicians with immediate clinical insights.

Gabriel Sanchez, Ph.D., CEO, and co-founder of Enspectra Health described the team’s excitement at receiving FDA clearance for the VIO System.

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

He noted that it was the first multiphoton imaging modality to ever be cleared by the FDA in over 25 years, and this bodes well for the future of medical imaging.

“This milestone clearance is not only an achievement for Enspectra, but also for the medical imaging world. [It displays] a bold vision for the future of microscopy. Consider the impact of X-Ray, CT, MRI, Ultrasound, PET, Confocal, OCT, etc. in their respective medical fields.”

Redefining skin condition evaluation

Reported in the prospective, multicenter VISTA US Pivotal Study, the VIO System has been proven safe and effective in practical clinical settings. This groundbreaking technology provides in vivo images of tissue, aiding physicians in forming clinical judgments by capturing details such as blood vessels, collagen, pigment, stratum corneum, hair shafts or follicles, solar elastosis, hyperkeratosis, atypia, and epidermal disarray within and through the epidermis. 

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Dermatologists or pathologists with skin histology training are intended to interpret VIO images. During the clinical study, physicians achieved over 90% average accuracy in identifying skin features on VIO images, surpassing study endpoints.histology training. Physicians in the clinical study were able to identify skin features on VIO images with >90% average accuracy, exceeding study endpoints.

“The VIO System has tremendous potential for evaluating skin in clinical practice,” stated Manu Jain, M.D., Memorial Sloan Kettering. “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.” 

A limited number of systems will be made available to select clinical partners. Enspectra Health plans to pursue additional indications and advance its AI/ML clinical decision support algorithms further.

About Enspectra Health

Enspectra Health, a pioneering private health tech enterprise, is at the forefront of revolutionising skin evaluation with its groundbreaking virtual biopsy approach. 

Integrating reflectance confocal and multiphoton laser scanning microscopy, their innovative technology produces real-time, multispectral cellular-level images, eliminating the need for incisions. This advancement enables instant assessments of diverse skin tissues, aiming to reduce unnecessary biopsies and enhance early disease diagnosis.

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