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# PhotoniCare Middle Ear Scope Cleared
- URL: https://www.fdaweb.com/photonicare-middle-ear-scope-cleared/
- Published: 2020-01-06T12:00:00.000Z
- Updated: 2026-09-14T15:57:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145772

FDA has cleared a PhotoniCare 510(k) for its TOMi scope for non-invasive imaging of the middle ear. The device uses optical coherence tomography high-resolution depth imaging to determine the presence or absence of fluid in the middle ear and characterize the fluid type, the company says. It says that current tools can only provide a view of an eardrum’s surface, whereas the TOMi scope’s “advanced light-based technology could dramatically alter the way children with ear problems are evaluated.” PhotoniCare says the device can assist with frequent misdiagnosis of middle ear infections, reducing antibiotic use and referrals to surgery.