Submitted by kBLASTER Team on
by Fink Densford for MassDevice
The U.S. Food and Drug Administration (FDA) announced it has de novo cleared the SENSIMED TRIGGERFISH ophthalmic product with new product classification code PLZ. The FDA last week said it cleared SensiMed’s Triggerfish sensor-embedded contact lens designed to detect fluctuations in the eye’s volume to identify the optimal time to measure intraocular pressure.
The Triggerfish features a sensor embedded in a soft silicone contact lens designed to detect changes or fluctuations in the patient’s eye volume. The lens is designed to be worn for a maximum of 24 hours and wirelessly transmit data from the sensor to an adhesive antenna worn around the eye.
Data from the device can be transferred via Bluetooth to a computer where a clinician can monitor the range of time during the day that eye pressure may be increasing, the company said.
“The Triggerfish gives the clinician 24-hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained. This information can help determine the most critical time of day for the clinician to measure the patient’s IOP,” FDA Center for Devices and Radiological Health Office of Device Evaluation acting director Dr. William Maisel said in an FDA press release.
Currently, measurements are taken of the eye during check-up appointments. The issue with that is providers get only a tiny snapshot of a metric that changes throughout the day. In glaucoma, the pressure is known to be greatest overnight and lowest during the day.
The Triggerfish won FDA clearance for adults age 22 and older as instructed by a health care professional. The clearance came based on several studys of the safety and tolerability of the lenses, as well as the effectiveness of the device measurement, the company said.
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