Topcon Healthcare, Inc. announced a major business —and product—acquisition: Toku, Inc., developer of non-invasive, artificial intelligence (AI)-controlled diagnostic and retinal imaging technology.
Let's take a closer look at Toku.
Headquartered in New Zeland—with U.S. headquarters in San Diego, California—the commercial medical device company’s patented technologies target three key therapeutic areas:
- Biological age
- Cardiovascular disease (CVD) risk
- Chronic kidney disease (CKD)
What these platforms do: Leverage standard color fundus photographs (in other words: retinal images) to deliver real-time assessments for biological age, CVD risk, and CKD.
Now, before we get into that tech… give me a brief look at this acquisition.
Per the companies’ definitive agreement, the deal is part of Topcon’s ongoing Healthcare from the Eye initiative launched in 2024.
- For a refresh on this oculomics-based approach, click here
Side note: Since being announced, that endeavor has been at the focal point of several new partnerships, acquisitions, investments, and launches.
Was a price tag attached?
No—not any that was publicly shared, at least.
Okay … and what’s the gist of these AI models?
All three of Toku’s diagnostic platforms are built on a large dataset of retinal images linked back to clinical data:
- CLAiR
- BioAge
- MyKidneyAI
Their purpose: Each is designed to integrate with eyecare professionals’ (ECPs) existing retinal imaging cameras, offering a real-time risk assessment for various systemic diseases.
Tell me about these platforms.
Toku’s AI-based platforms are in varying stages of clinical development within the United States, including receiving regulatory approval in certain regions of the world.
- As such, we’ll start with the BioAge Test.
What it does: Via those aforementioned retinal imaging techniques, this test evaluates biometric markers—based on vascular and metabolic indicators—within the human body to potentially and accurately:
- Measure a patient’s biological age
- Produce a detailed report on that patient’s overall health and health risks
Give me more on this.
Click here for a more detailed overview of the platform (note: it’s not a medical device)—as well as the technology behind it and three-step testing process.
Importantly, though: The test only takes a few short minutes to conduct during clinic visits.
- And even better: Results are (reportedly) generated within 20 to 40 seconds
And if you’re looking for a deeper dive into the science and technology behind the test, check out this explanation.
Is this available in the United States yet?
While not FDA-cleared yet, BioAge was part of a recent partnership announced last month between Toku and Optos.
- Those details: BioAge will be added to Optos’ ultra-widefield (UWF) imaging devices.
Got it. And those other two technologies?
Already cleared in the European Union, the CLAiR platform (which, again, offers real-time and non-invasive CVD risk assessment) has received FDA Breakthrough Device Designation.
- Most notably: This tech is reported to give instant results, involve zero radiation, and cost less than other standard CVD risk calculations based on biomarker and blood testing.
- Check out a visual of the system.
And as for MyKidneyAI—what we know is:
- The technology utilizes retinal images (captured during routine eye exams) to detect the potential elevated risk for CKD in diabetic patients.
Got it. Now circle back to this Topcon integration.
By connecting these platforms (once they’re available for commercial use, that is) to Topcon’s digital ecosystem, the intent is to “make non-invasive, AI-driven risk screening widely accessible across primary care, eyecare and telehealth environments.”
Other major utilizations involved in this will include:
- Topcon’s Harmony, a cloud-based digital health information platform (details here)
- To establish a regulatory and commercial pathway for delivering oculomics-based solutions to patients
- Collaboration with the company’s Alliance for Healthcare from the Eye initiative (launched in May 2025)
- To improve population health outcomes, expand access, and reduce overall healthcare costs
And how will the acquisition benefit both players in this?
Aside from the broader application of its technologies, the deal will reportedly help to accelerate the regulatory clearances and commercialization of Toku’s investigational platforms.
And for Topcon: This accelerated growth will also extend to its targeted field of oculomics, according to Topcon CEO and President Ali Tafreshi.