FDA clears scanner for checking ear infectionsMarch 6, 2020
PhotoniCare received FDA 510(k) clearance for its hand-held, non-invasive imaging device TOMi Scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections.
The 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 the fluid is present and characterise its type and density, even in cases with heavy wax build-up.
Designed for use by nurse practitioners, physician assistants or other technicians, PhotoniCare said it plans to begin its launch of the TOMi Scope at select locations in the US in the near future with a larger, national rollout planned for later in 2020.