Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging. VIO, the first of its kind technology, combines reflectance confocal and multiphoton microscopy to enable cellular resolution, cross-sectional imaging of skin in seconds. Easily portable and handheld, VIO digitizes pathology directly from a patient’s skin to provide clinical insights for physicians.
“We are thrilled to receive FDA clearance for the VIO System. This is the first multiphoton imaging modality to ever be cleared by the FDA,” said Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health. “This significant achievement is the result of the excellent work by the Enspectra Health team and our clinical advisors. Our submission was cleared by the FDA ahead of plan, underscoring our ability to successfully drive an innovative technology from concept to clearance.”
The VIO System was evaluated in the prospective, multicenter VISTA US Pivotal Study, demonstrating that it is safe and effective in a practical clinical environment. The technology captures in vivo images of tissue – including blood vessels, collagen, pigment, stratum corneum, hair shafts or follicles, solar elastosis, hyperkeratosis, atypia, and epidermal disarray – in and through the epidermis, to assist physicians in forming a clinical judgment. VIO images are intended to be interpreted by dermatologists or pathologists with skin 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,” said 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.”
Limited systems will be made available to select clinical partners. Enspectra Health plans to pursue additional indications and further advance its AI/ML clinical decision support algorithms. For more information, please visit www.enspectrahealth.com.
About Enspectra Health: Enspectra Health is an emerging, privately held health tech company pioneering the virtual biopsy to transform the way physicians evaluate a broad spectrum of skin conditions. The Company’s novel technology combines reflectance confocal and multiphoton laser scanning microscopy to generate real-time, multispectral images at the cellular level, without the need for an incision. The technology allows for an instantaneous evaluation of rich, digital pathology images of various skin tissues, with the ultimate goal of minimizing unnecessary biopsies and facilitating earlier disease diagnosis.