www.fdanews.com/articles/195388-photonicares-ear-imaging-technology-gets-fda-ok
PhotoniCare’s Ear Imaging Technology Gets FDA OK
January 6, 2020
PhotoniCare’s TOMi Scope has received 510(k) clearance from the FDA for non-invasive imaging of the inner ear.
The device uses optical coherence tomography high resolution imaging to determine the presence and type of fluid in the middle ear, which can help to establish if a patient has an infection.
The TOMi Scope directly visualizes fluid contained in the middle ear and can gauge fluid density even in the presence of earwax.