iCare, a subsidiary of Revenio Group, and Mediwhale Inc. have agreed to explore a strategic collaboration that will integrate both companies’ areas of expertise: artificial intelligence (AI), preventative screenings, and retinal imaging.
First, a look at these players.
With U.S. headquarters in Raleigh, North Carolina, iCare was launched in 2003 as a global, advanced healthcare technology company with a medical devices product line for screening and diagnosing ocular diseases.
- Its device portfolio extends to retinal imaging, rebound tonometers, fundus perimeters, and microperimeters (to name a few). Click here for a closer look.
As for Mediwhale: The South Korea-based, AI-powered health diagnostics company is using non-invasive retina scans to predict cardiovascular disease (CVD), systemic diseases (kidney and ocular), and biological age.
How it’s doing this: Via deep learning algorithms designed to detect future risk for diseases—before the onset of symptoms.
Talk about this partnership
Per the agreement, the companies will integrate two key technologies to create a retinal imaging-based “gateway to systemic health” that supports both early intervention and holistic patient care.
Those technologies:
- iCare’s DRSplus fundus imaging system (within its screening solution)
- Mediwhale's Dr. Noon CVD software
Explain each of these.
iCare’s DRSplus fundus imaging system is a high-speed, fully automated fundus camera utilizing white light-emitting diode (LED) illumination to offer high-quality images via TrueColor Confocal Technology.
- About TrueColor: This is a high image quality standard that provides detail-rich, 45° retinal images with greater sharpness, optical resolution, and contrast when compared to traditional fundus camera imaging.
Tell me more.
The “easy-to-use” and intuitive system allows for imaging through pupils as small as 2.5 mm—with no need for dilation—during a quick examination process.
Among its offerings:
- Capacitive touch screen for easy magnification and image review
- Optional remote viewer feature for data review
- A live infrared (IR) preview
- Automated capabilities (auto-alignment, -focus, -exposure, -capture, and -montage)
- A mosaic function for retinal panoramic views up to 80°
Can I get a visual of it in action?
See below.
iCare DRSplus - TrueColor Confocal Fundus Imaging System
Now to the other technology in this collaboration.
Previously known as Reti-CVD, Mediwhale's Dr. Noon CVD software is an AI software that uses retinal imaging—specifically, one retinal scan per eye—to predict a suspected at-risk patient’s potential for CVD within the next 10 years.
This autonomous, non-invasive six-step process entails:
- Steps 1 and 2: Identifying the at-risk patient (aged 20-80) and consulting with a clinician
- Step 3: Capturing one retinal image per eye using a fundus camera (such as the iCare DRSplus)
- Step 4: Uploading the images to a clinician’s digital server or cloud platform
- Steps 5 and 6: AI automatically analyzing the images to assess the patient’s CVD risk and generating a report based on the determination
- Patients are categorized into risk groups (low, medium, and high) to help clinicians determine appropriate medication and lifestyle interventions
And how does this compare to standard CVD tests?
We answered this question here in our 2024 coverage of Mediwhale securing Series A2 funding to support the technology.
Also in this reporting: A rundown on recent clinical evidence demonstrating its “ability of deep learning to bring automated CVD risk quantification which cannot be performed by humans.”
Are both technologies commercially available?
Mediwhale’s software is commercially available in South Korea, Dubai, the United Kingdom, Italy, and has received regulatory approval in eight regions.
- In the United States: The company is currently pursuing FDA authorization via the DeNovo Pathway and has already met with the federal agency for multiple pre-submission meetings.
- The estimated timeframe: H1 2026.
As for iCare’s device … yes, it’s already received FDA 510(k) clearance (in 2019 and 2021 for an upgrade clearance) as a Class II ophthalmic diagnostic device and is commercially available for use in the United States.
… so where and when will these integrated technologies be available for use?
Great question … and the answer isn’t exactly clear at the moment.
Considering only one of the two products are currently FDA-cleared and available, it’s likely that any potential in-clinic usage in the United States is on hold until the Mr. Noon CVD system receives (potentially) De Novo authorization.
Outside the U.S., however, the collaboration supports and accelerates the global adoption of Mediwhale’s technology and expanding role of retinal screening beyond ophthalmology.
- “We are establishing a new standard where the retinal exam is no longer just for eye health, but a critical tool for managing metabolic syndrome,” stated Kevin Taegeun Choi, Mediwhale CEO.
Contact the companies (here and here) for more details on this integration.