PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections.
The TOMi Scope diagnostic device uses optical coherence tomography, or OCT, to scan the middle ear with near-infrared light and provide a cross-section image similar to an ultrasound. It can then determine whether fluid is present and characterize its type and density, even in cases with heavy wax buildup.
“Current tools can only provide a view of the surface of the eardrum, forcing physicians to make an assessment with very limited information, or to employ invasive surgical procedures to accurately identify middle ear pathologies,” said Diego Preciado of Children’s National Hospital in Washington, D.C., who served as a lead investigator for the device’s clinical studies.