FDA approves Triggerfish diagnostic device for monitoring onset of glaucoma- Sensimed

The FDA allowed marketing of Triggerfish, a one-time use contact lens diagnostic device, from Sensimed, that may help practitioners identify the best time of day to measure a patient�s intraocular pressure (IOP). Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma. The FDA reviewed the data for the Triggerfish through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

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).

Comment: The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye�s volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the 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.