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# FDA De Novo Approval for Eye Pressure Monitor
- URL: https://www.fdaweb.com/fda-de-novo-approval-for-eye-pressure-monitor/
- Published: 2016-03-07T12:00:00.000Z
- Updated: 2026-09-15T02:41:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134974

> FDA has approved a Sensimed de novo marketing application for the Triggerfish, a single-use contact lens that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP). Elevated IOP can be associated with glaucoma-related optic nerve damage. The silicone contact lens has a sensor embedded in it that detects tiny changes or fluctuations in an eye’s volume. The device is worn for 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye, according to an agency [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm489308.htm?ref=fdaweb.com). A portable data recorder can transfer the data via Bluetooth to a clinician’s computer, which shows the range of time during the day the pressure of the eye may be increasing. “The device does not actually measure IOP, is not intended to be a diagnostic tool and is not used to correct vision,” FDA says.