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FDA grants marketing approval for Triggerfish IOP monitoring device

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The FDA approved the marketing of the Triggerfish device, a soft silicone lens with an embedded sensor that detects tiny changes or fluctuations in the eye’s volume, according to an agency press release.

The Triggerfish (Sensimed AG) allows data from the contact lens to be transferred via Bluetooth to the clinician’s computer, which shows the clinician when there is an increase in IOP.

“This information can help determine the most critical time of day for the clinician to measure the patient’s IOP,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release.

Data for the marketing approval were reviewed by the FDA through the de novo premarket review pathway.

The Triggerfish does not measure IOP, is not intended to be a diagnostic tool and is not used to correct vision, the release said.