Evoq Technologies announced the official FDA registration, Class I medical device classification, and U.S. commercial launch of its latest wearable diagnostic device for eyecare: Twilight.
First, a look at Evoq.
Founded in 2021 and based in Henderson, Nevada, the privately-held medical device company is developing wearable and accessible diagnostics that detect retinal and neurological diseases earlier (prior to vision loss).
Its mission: To make early detection scalable and function via mobile, cloud-connected devices designed to outperform imaging.
- Included in its portfolio is the SightGard platform, a suite of tools designed to assist eyecare providers (ECPs) in early retinal disease detection.
- Among these tools is the company’s first product: Smart ERG, an FDA-registered, smartphone-based, full-field electroretinogram/visual evoked potential (ERG/VEP).
Now to Twilight.
Also included in Evoq’s SightGard platform, the Twilight Dark Adaptometer is a smartphone-based portable device that measures dark adaptation performance (how the retina recovers from bright light to darkness) for retinal health monitoring.
The intent: To streamline the functional vision assessment process and provide early detection of retinal dysfunction for diseases such as:
- Age-related macular degeneration (AMD)
- Diabetic eye disease
- Inherited retinal diseases (IRDs)
And what features does the device come with?
The dark adaptometer is packaged in a durable storage case with the following components:
- A handheld console
- Includes an intuitive interface and automated protocols (for consistent data collection)
- Provides audio guidance and flash prompts during use
- Photostimulator headset
- Disposable light-blocking eye mask
- This is attached to the inside of the headset prior to patient use
See here for a visual.
Is this tool used in the clinic?
It can be … but it’s also primarily intended for at-home patient use.
In fact, Evoq noted that “prescribed home-based use” of the device “enables patients to actively engage in tracking their visual function” in between in-office clinical visits.
- Along these lines: Patients can also access a patient portal to keep track of their functional performance longitudinally.
So how can ECPs maintain regular functional monitoring?
That would be via Twilight’s real-time data capture and secure cloud storage (with algorithm-based analysis), which allows ECPs to remotely review and track patient results over time.
And circling back to that optional clinic use: The company stated that ECPs can also use the device to perform a fast, technician-led dark adaptation test in “any clinical setting” (including exam rooms, pre-test areas, and satellite clinics).
- Importantly: Twilight reportedly “eliminates the need for specialized dark rooms, pupil dilation, or complex logistical changes, ensuring no disruption to existing clinic workflow.”
And with this FDA registration … is there a CPT code for it?
Yes! CPT 92284 (for dark adaptation examination with interpretation and report) is reimbursable for qualifying patients.
Last question: Where can I find this for my clinic?
Reach out to the company to request pricing and availability.