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Home » Olympic Ophthalmics Gets FDA Clearance for its iTEAR100 Neurostimulation Device
Olympic Ophthalmics Gets FDA Clearance for its iTEAR100 Neurostimulation Device
Olympic Ophthalmics has been granted 510(K) clearance by the FDA for its second-generation iTEAR100 device, a prescription neuromodulation therapy to increase tear production.
The device features telehealth tools, including prescription-download capability and activation through a mobile phone app, according to the Issaquah, Wash.-based company.
Olympic Ophthalmics is conducting three clinical trials of the iTEAR100, including a study in patients with newly diagnosed dry eye disease who are using iTEAR100 as their first treatment; a virtual telehealth trial where iTEAR100 is prescribed, monitored and titrated by a physician without the patient having to visit a doctor’s office; and a label expansion study to optimize basal tear secretion vs. reflex tearing.
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