Kent Imaging Receives ISO 13485 Certification
Kent Imaging announced today that it has passed the ISO 13485 requirements for a comprehensive quality management system for the design and manufacture of medical devices. This new certification marks another key milestone in Kent’s continuous improvement strategy. It demonstrates Kent’s commitment to quality and customer satisfaction. Achieving this level of certification allows Kent to pursue additional regulatory clearances for its medical imaging device including Health Canada clearance.
About SnapshotNIR:
ACTIONABLE, ACCURATE DATA
THE POWER OF DIAGNOSTIC-DRIVEN WOUND CARE IS IN YOUR HANDS
Chronic wounds are a health problem with significant reductions in quality of life and can have devastating consequences such as limb amputations and premature death. Current diagnostic tools to assess tissue health are either costly or difficult to employ (or both), and visual assessment alone is not adequate to see the whole picture. Historically there have been no easy or cost-effective ways to directly assess tissue viability. SnapshotNIR is a medical imaging device that visualizes and maps tissue oxygen saturation in the capillary network.
SnapshotNIR has features that expand the application of near-infrared spectroscopy (NIRS) to include imaging on almost all skin tones, advancing tissue assessment for physicians and patients. The device measures tissue oxygen saturation (StO2), oxyhemoglobin and deoxyhemoglobin in nearly all individuals at any location on the body. With the unique Hemoglobin View, providers can track the wound healing trends, to ensure that oxyhemoglobin increases, while deoxyhemoglobin decreases.
Read about the current stage of the device.
About Kent Imaging:
Kent Imaging, located in Calgary, Alberta, Canada, is a leading innovator in near-infrared tissue oxygenation imaging, which develops, manufactures, and markets medical technology that supports real-time decision-making in wound care, vascular and surgical subspecialties. Kent holds multiple patents in oxygen imaging technology and continues to provide innovative and advanced diagnostic imaging solutions to aid healthcare systems nationally and internationally.