Building the First FDA Approved Autonomous AI in Healthcare – Dr. Michael Abramoff and Seth Rainford

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Originally Posted On: https://thehcbiz.com/180-first-fda-approved-autonomous-ai-in-healthcare/

Have you ever had an idea that you just had to make real? No matter what it took… no matter what obstacles were in your way… no matter how many times people told you no… you just couldn’t stop until it existed? Well, this is one of those stories. It begins with an idea in 1988 and leads to the first-ever autonomous AI in healthcare to be approved by the FDA for diagnosis without physician input.

Dr. Michael Abramoff is a neuroscientist, a practicing physician, and holds a Ph.D. in Artificial Intelligence and Machine Learning. I know… slacker. In 1988, Michael was working on artificial intelligence during his residency and began to think a computer could diagnose diabetic retinopathy. Given the technology available at the time, this idea may have been a bit of a stretch. Still, Michael set out to prove it could be done.

On this episode, we talk with Dr. Michael Abramov and Seth Rainford about the 30-year journey that led to the founding of Digital Diagnostics, and the first-ever FDA-approved Autonomous AI in healthcare. Plus, we explore the challenges they continue to work through as they commercialize their product.

The journey itself is remarkable and each obstacle and resolution will be relevant to any digital health entrepreneur – especially those in AI and diagnostics.

Of our 180 episodes, this is one of my favorite stories so far. It’s fascinating, entertaining, and incredibly useful. I hope you benefit from it as much as I did.

Dr. Michael Abramoff, MD, Ph.D. is the Founder and Executive Chairman of Digital Diagnostics, the autonomous AI diagnostics company which was the first in any field of medicine to get FDA authorization for an autonomous AI. In primary care, the AI system can instantaneously diagnose diabetic retinopathy and diabetic macular edema at the point of care. Dr. Abramoff’s achievements include development of the first ethical foundation for autonomous AI (2020), the first incorporation of AI into standards of care, as well as ultimately widespread payment for AI as a diagnostic service (2020). These achievements have already led to better outcomes for thousands of patients worldwide, through improved access, lower cost, and higher quality of care.  As a Professor of Ophthalmology at the University of Iowa, Dr. Abramoff continues to see patients and has mentored dozens of graduate students, ophthalmology residents, and retina fellows. He currently chairs the Foundational Principles for Ophthalmic Imaging and Algorithmic Interpretation AI workgroup instigated by FDA.

Seth Rainford is the President and COO at Digital Diagnostics where he focuses on expanding market opportunities and driving operational excellence within the company. He brings more than a decade of executive experience to Digital Diagnostics including the successful management of large-scale P&L’s, strong organic & inorganic business development expertise, as well as complex multi-site operations leadership within the healthcare industry.

Digital Diagnostics (formally IDx) is a leading AI diagnostic healthcare technology company, paving the way for automated diagnosis to become the new standard of care. Founded in 2010 by Dr. Michael Abramoff, a physician/scientist and computer engineer, Digital Diagnostics has created a unique, patented biomarker-based approach to build algorithms to “think” like a physician. These algorithms are integrated into easy-to-use systems that can make clinical decisions without human intervention, removing the diagnostic burden of common diseases from specialists. The FDA De Novo cleared Digital Diagnostics’ first diagnostic system for diabetic retinopathy and diabetic macular edema in 2018, which is rapidly gaining adoption among the largest health systems in the U.S and around the world.

• LinkedIn – https://www.linkedin.com/company/digital-diagnostics
• Facebook – https://www.facebook.com/AItheRightWay
• Twitter – https://twitter.com/AItheRightWay
• Website – https://www.digitaldiagnostics.com/

• Episode 179: Making Machine Learning Available to the Masses – Dr. Taha Kass-Hout – AWS
• Episode 171: Office Hours: Does My Software Need FDA Clearance (SAMD)?
• Episode 162: What’s up with IBM Watson Health? A Discussion on the State of AI in Healthcare with Paddy Padmanabhan
• Episode 159: A Practical Look at Machine Learning in Healthcare with Josh Miramant
• Episode 147: Applying Conversational AI to Reduce Provider Burnout from HealthIMPACT Live
• Episode 116: Enhancing Diagnostic Accuracy with Art Papier of VisualDx
• Episode 91: Deep Medicine with Dr. Eric Topol
• Episode 43: Demystifying Big Data and Machine Learning for Healthcare w/ Prashant Natarajan

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