The Food and Drug Administration issued de novo approval to SENSIMED, a Lausanne, Switzerland firm, to introduce its Triggerfish continuous eye volume monitoring system. The Triggerfish allows physicians to decide when is the best time to measure the intraocular pressure that changes throughout the day and single in-office tests may not be at all indicative of the actual changes going on inside the eye. The technology should allow for earlier detect of glaucoma before symptoms become apparent.
The system relies on an electronic contact lens that has a sensor built-in that detects fluctuations in the shape of the lens. A special antenna attached around the eye powers and communicates with the contact lens, grabbing readings that are then passed to a portable data recorder.
The system is worn for up to 24 hours and the gathered data is transferred wirelessly using Bluetooth to the physician’s PC for review.
Some details from FDA’s announcement:
The Triggerfish is indicated for use in adults age 22 and older under the direction and supervision of a health care professional. Clinical data supporting the marketing authorization of the Triggerfish included several studies of the safety and tolerability of the contact lenses and the effectiveness of the device measurement. The effectiveness of the device was demonstrated by showing an association between the Triggerfish device output and IOP fluctuation. The most common temporary side effects were pressure marks from the contact lens, ocular hyperemia (red eyes) and punctate keratitis (irritation of the cornea).
Product page: SENSIMED Triggerfish…