The FDA has granted De Novo marketing authorization to Notal Vision Inc. for its SCANLY Home OCT (optical coherence tomography) device, designed for patients diagnosed with wet (neovascular) age-related macular degeneration (nAMD).
First things first: What’s a De Novo request?
A De Novo classification is a “risk-based classification process” to provide a marketing pathway to classify novel medical devices that “provide reasonable assurance of safety and effectiveness for the intended use.”
Important to note: There can’t be a predicate device—a device that’s already legally marketed for the same intended use.
Major difference from 510(k) classification: Unlike the De Novo, this relies heavily on determining a “substantial equivalence” to an existing medical device.
Gotcha. Now refresh me on this company.
Founded in 2000 and based in Manassas, Virginia, Notal Vision is an ophthalmic diagnostic services company developing at-home testing via artificial intelligence (AI)-driven data to extend eye disease management for patients with AMD.
Among its technologies is the ForeseeHome AMD Monitoring Program, an FDA-cleared, remote, AI-enabled device intended to help eyecare professionals (ECPs) in the conversion from dry intermediate to wet AMD.
Bonus: See here for our coverage of 10-year data supporting its use for improving long-term visual acuity (VA).
Now what to know?
First, we need to talk about the Notal Vision Monitoring Center (NVMC).
What it is: The NVMC is an independent diagnostic testing facility that operates as a full-service monitoring center and medical service provider led and supported by certified ophthalmologists and patient engagement specialists.
Essentially: It’s considered the “epicenter for patient and physician engagement” providing testing result collection, analysis, and dissemination.
Even further: The center manages insurance and benefits verification, phone support, and compliance reminders on behalf of an ECP’s office.
Is it time to talk about this OCT device?
Yes! The SCANLY device is designed as a self-operated and comprehensive remote patient monitoring service that captures spectral-domain (SD-)OCT images in a 10x10° area centered on the point of fixation.
- The scan time: less than 1 minute per eye
Then: Once a patient captures these images, they’re immediately transferred through a built-in wireless connection for analysis via the company’s in-house Notal Health Cloud.
What kind of analysis is done on them?
The AI-based Notal OCT analyzer (NOA) then “segments and estimates the volume of hypo-reflective spaces (HRS)” on the OCT images.
Note: HRS are known as key biomarkers for managing nAMD.
Also: NOA is Notal’s deep learning-based algorithm for automatic quantification of retinal fluid (another key biomarker for nAMD treatment efficacy).
And what can physicians do with this information?
Per Notal Vision, an ECP can view the data and “set eye-specific notification criteria” such as volume thresholds, as well as set and receive alerts via a HIPAA-compliant web portal.
So what kind of billing codes does the device fall under?
Specific current procedural terminology (CPT) codes for remote OCT are already available for use, including 0604T, 0605T, and 0606T
These enable ECPs/NVMC to bill for services every 30 days, according to Notal Vision.
For this device: The company reported it will work with Medicare Administrative Contractors to establish coverage and payment for remote OCT billing codes.
And what kind of clinical testing has it undergone?
Two pivotal U.S.-based studies, actually.
- The first: a single-arm study with a lengthy title of Home OCT Fluid Visualization Agreement Study at Multiple Retinal Clinics With Placement of One Home OCT Device in the Home of Each NV-AMD Subject in the US for 5 Weeks (NCT04907409)
- The second: a longitudinal, multi-center study titled The Evaluation of the Agreement and Precision of the Notal Vision Home OCT in the Automatic Fluid Quantification in Patients With NV-AMD (NCT05202587)
Give me the rundown on those.
In total, both studies enrolled over 500 participants (n=120 for the first; n=386 for the second, estimated per Clinical Trials) diagnosed with nAMD.
Their purpose: Evaluate the ability of nAMD patients to use the SCANLY device to set up and self-image their eyes at home (ie: the rate of successful imaging attempts).
And what were the findings?
Each of the studies demonstrated that the use of the SCANLY device is considered a “safe and efficacious way to visualize intra- and subretinal hypo-reflective spaces,” according to the company.
More specifically, 97% of patients in the second study were successful in obtaining OCT images on their own, taking an average of 48 seconds per image.
Plus, out of 5,426 scans of their study eye (averaging 5.9 scans/week), 97% of imaging attempts were usable, Notal Vision reported.
So … where can I find this?
Click here (and scroll all the way down) to learn about adding this device for your nAMD patients.
Click here (and scroll all the way down) to learn about adding this device for your nAMD patients.