Toku’s AI: Heart Condition Check via Eye Scans

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November 17, 2023

Toku's AI Platform: Heart Condition Prediction through Eye Scans

In today’s fast-paced world, advancements in technology continue to revolutionize the healthcare industry. One such groundbreaking innovation is Toku’s AI platform, which is set to transform the way heart conditions are predicted and diagnosed. By harnessing the power of artificial intelligence and ocular imaging, Toku’s platform, known as CLAiR, can detect cardiovascular risks and related diseases through a non-invasive retina scan.

This cutting-edge technology has the potential to revolutionize routine eye exams and provide doctors and healthcare providers with valuable insights into their patients’ cardiovascular health. Join us as we delve into the world of Toku’s AI platform and explore how it is poised to make a significant impact in the field of healthcare. Stay with us in this blog post for more information.

Ehsan Vaghefi, the CEO and co-founder of Toku, was raised in an environment deeply connected to visual impairment. His father lost his eyesight at the age of four due to congenital glaucoma, leading him to engage with the Blind Foundation in their home country of Iran. Growing up, Vaghefi had a close circle of friends, the majority of whom were either blind or had a parent experiencing blindness.

Vahefi initially considered a career as a clinician to assist individuals facing challenges similar to those his father encountered. However, intrigued by the potential of technology to extend aid to a broader audience, he shifted his focus to health technology. This redirection led him to establish Toku, where he explores the applications of ocular imaging and its diagnostic capabilities.

“In my early years, I recognized the inherent limitations of being a clinician, constrained by the finite hours in a day. This realization fueled my commitment to leveraging technology and innovation to make healthcare accessible to the masses,” explained Vaghefi. He is not only the CEO of Toku but also an associate professor in Optometry and Vision Science at the University of Auckland. With a notable track record, Vaghefi holds five patents, has authored 50 publications, and secured over $15 million in grants for research focused on the early detection of diseases through ocular imaging.

“I’ve dedicated every day of my adult life to tirelessly pursue the goal of making affordable and accessible disease screening available to everyone, ensuring no child has to grow up with a disabled or deceased parent.”

Toku’s core premise is founded on the robust connection between glaucoma and cardiovascular conditions. By examining a patient’s eyes, clinicians can gain insights into the functionality of the cardiovascular system. The flagship product, CLAiR, is a non-invasive, AI-powered retina scan and technology platform. This innovative solution can identify cardiovascular risks and associated diseases, including stroke and type 2 diabetes.

The platform’s approach is groundbreaking: CLAiR utilizes AI to interpret subtle signals from the blood vessels captured in retinal images, boasting the capability to calculate heart disease risk, hypertension, or high cholesterol in just 20 seconds. With seamless integration into existing retinal imaging cameras, these diagnostics could seamlessly become part of any routine eye exam.

What is the purpose of scanning inside the eye?

The purpose of scanning inside the eye is to detect various health conditions and diseases. The retina, located at the back of the eye, contains blood vessels that can provide valuable information about a person’s overall health. By examining the retina, healthcare professionals can identify signs of cardiovascular risks and related diseases such as stroke, hypertension, and type 2 diabetes. The scan can also help detect eye-specific conditions like glaucoma. Scanning inside the eye using advanced imaging technology and AI-powered analysis allows for early detection and intervention, potentially preventing further complications and improving patient outcomes.

Despite its early stages, the company secured an $8 million Series A funding round this year from U.S. optical retailer National Vision and Japanese firm Topcon Healthcare. Notably, the U.S. Food and Drug Administration (FDA) recently granted CLAiR “breakthrough device status,” emphasizing its potential significance, especially considering its compatibility with existing retinal imaging cameras.

The FDA’s breakthrough device designation remarkably expedites the market entry process, according to the CEO. This designation provides Toku with access to a specialized FDA team of experts collaborating with the startup to streamline and de-risk the accreditation process.

Furthermore, Vaghefi emphasized, “Every product that secures its ultimate FDA approval through the breakthrough designation program stands a chance to receive an automatic current procedural terminology (CPT) reimbursement code immediately after the final approval.”

However, it’s important to note that the product is not currently available on the market. Once it receives clearance and accreditation from the FDA, the startup aspires to become the inaugural medical device company in the U.S. offering a cost-effective, non-invasive method for detecting cardiovascular disease (CVD) through retinal imaging.

Founded in 2019 in Auckland, New Zealand, the startup recently relocated its headquarters to San Diego, California, earlier this year. Toku is gearing up to commence its pivotal trial in mid-2024, with plans to launch the product by the end of 2025. Collaborating with strategic backers like Topcon Healthcare and National Vision, the company is diligently preparing for the rollout post the final approval. It’s worth mentioning that Toku is not the pioneer in developing a tool for predicting cardiovascular disease through retinal analysis.

Five years ago, Google and Alphabet’s Verily announced the development of an AI algorithm to predict heart disease risks through eye scans, but its implementation is still pending. Notably, Toku’s AI tool could potentially replace traditional diagnostic tests like CT scans, MRIs, and X-rays. Similar ventures include South Korea-based MediWhale, which also employs AI-driven non-invasive retina scans for diagnosing cardiac and kidney disorders.

Toku envisions deploying its technology for routine eye exams, targeting asymptomatic adults. The plan is to integrate it into retail optometry, primary care offices, ophthalmology clinics, and pharmacies equipped with retinal cameras.

Once CLAiR identifies individuals with elevated cardiovascular risk, they will be referred to their primary care providers for additional tests. Toku emphasizes a commitment to privacy and data security, aligning with the Health Insurance Portability and Accountability Act (HIPAA) and ISO 13483 standards. This ensures that only authorized parties can access a patient’s health data.

The CEO clarified, “We do not use patient information for research or AI training unless explicitly stated. Patients can request data deletion at any time, and we promptly comply. We adhere to data sovereignty in every jurisdiction, utilizing local servers and infrastructure.”

Conclusion

Toku’s AI platform represents a significant leap forward in the early detection and prediction of heart conditions. By utilizing ocular imaging and AI technology, Toku has developed a non-invasive and efficient method to assess cardiovascular risks and related diseases. This groundbreaking platform has the potential to revolutionize routine eye exams, providing doctors and healthcare providers with valuable insights into their patients’ cardiovascular health.

With its recent breakthrough device designation from the FDA, Toku is on track to become the first medical device company in the U.S. to offer an affordable and accessible way to detect the risk of heart conditions through eye scans. As Toku continues to advance its pivotal trial and prepare for market rollout, we can anticipate a future where heart condition prediction becomes more accessible and widespread, ultimately leading to improved patient outcomes and a healthier society.

What are your thoughts on Toku’s AI platform and its potential to revolutionize the early detection of heart conditions? How do you think the integration of AI technology into routine eye exams can benefit doctors and healthcare providers in assessing cardiovascular risks? How do you think Toku’s AI platform can impact the accessibility and affordability of heart condition detection for individuals across different healthcare settings? Share your insights below.