AI System for Predictive Burn Wound Assessment Receives FDA De Novo Clearance
The system utilizes multispectral imaging and algorithms to help clinicians determine the healing potential of burn wounds.
The system utilizes multispectral imaging and algorithms to help clinicians determine the healing potential of burn wounds.
The revision to the standard, effective June 1, 2026, specifies that annual electrical safety inspection by a certified electrician or biomedical engineer satisfies the equipment maintenance requirement for in-lab sleep testing programs.
The technology is no longer a standalone tool, but connective tissue linking devices, data, and clinical workflows.
The new EB-710US device aims to reduce infection risks and streamline procedure preparation by eliminating the use of disposable balloons.