FDA www.fda.gov permits the marketing of a device called “Triggerfish” manufactured by Sensimed AG located in Lausanne Switzerland www.sensimed.ch/en. The device is able to sense the optimal time to check a patient’s eye pressure which is important since increased eye pressure is associated with nerve damage common in glaucoma.
The marketing of a one-time use for a contact lens may help practitioners identify the best time of day to measure a patient’s Intraocular Pressure (IOP). 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.
The computer shows the range of time during the day that the eye pressure may be increasing. The device does not actually measure IOP, is not intended to be a diagnostic tool, and is not to be used to correct vision.
“The Triggerfish gives the clinician 24 hour continuous monitoring of changes in IOP patterns that otherwise could not be obtained,” said William Maisel, MD, Acting Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.”
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 substantially equivalent to an already legally marketed device.