PhotoniCare announced today that it won FDA 510(k) clearance for its TOMi Scope for non-invasive imaging of the middle ear to spot ear infections and more.
The TOMi Scope is designed to determine the presence or absence of fluid in the middle ear, as well as to characterize the fluid type, by using optical coherence tomography (OCT) high-resolution depth imaging. The scope allows physicians to visualize the fluid and measure its density.
Fluid in the middle ear is seen as a primary indicator for determining infection, and TOMi Scope is designed to eliminate speculation regarding the fluid. The visualizations and measurements provided by the scope provide physicians data upon which they can base their decisions. The scope could prove especially useful for pediatricians trying to determine whether a child’s ear is infected — a common challenge.
Champaign, Ill.–based PhotoniCare said it plans to immediately launch the TOMi Scope in a limited release across select U.S. locations, with a full launch across the country expected to come later in 2020.
“At PhotoniCare we set out to solve the massive problem of frequent misdiagnosis of middle ear infections, and the overuse of antibiotics and referrals to surgery in children that result,” PhotoniCare co-founder & CEO Ryan Shelton said in a news release. “We thank the FDA for clearing our TOMi Scope under a new product code unique to our technology, and look forward to bringing this innovation to doctors and patients very soon.”
“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,” added Dr. Diego Preciado of the Children’s National Hospital in Washington, D.C., a lead investigator for clinical studies of the device. “TOMi Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments.”