What happened
IDx, maker of autonomous AI diagnostic tool for diabetic retinopathy, has landed $33 million in Series A financing. This comes just months after its IDx-DR got the designation as the first FDA-cleared autonomous AI diagnostic system. The latest funding was led by 8VC with participation from Optum Ventures, Alpha Edison, and Heritage Provider Network.
Why it matters
Now the company plans to use the money to further develop additional diagnostic systems for its AI platform, as well as commercialize its diabetic retinopathy tool. Specifically the startup is looking into AI diagnostics for age related eye conditions.
“Our system is a platform and so with the network management tool center we have the ability to control, demand, download, and add additional diagnostics as they are approved,” Gary Seamans, CEO of IDx, told MobiHealthNews. “So specifically the next two AI algorithms that will be using our platform will be focused on age-related macular degeneration and glaucoma.”
In April, the Coralville Iowa-based startup recieved De Novo clearance for its autonomous AI diagnostic tool, which scans for diabetic retinopathy, a condition caused by damage to the blood vessels of the retina and can cause blindness. Dx-Dr’s algorithm analyzes images taken with the Topcon NW400 retinal camera and uploaded to a cloud server. The software is able to give physicians a binary result within a few minutes, either indicating that more than mild diabetic retinopathy is present and that the patient should be referred to an eye care professional, or that the screen is negative and should come back for normal annual testing.
“There is always confusion about the difference between an assisted AI and autonomous AI,” Seamans said. “That difference is so critical because we are familiar with assisted—it tells the radiologist look here, look there. But when you go to autonomous you are getting an AI system to do a diagnosis without involving a physician. So that is a big leap and that is a disruptive technology.”
Seamans said the technology is a game changer because it can be deployed in “front line” care centers like primary care facilities or to commercial providers like a CVS clinic. Experts recommend that individuals with diabetes get checked for diabetic retinopathy at least once a year. If the condition is caught early it is treatable, said Seaman. But getting patients to come in for that annual exam is tricky. Seamans notes that with this technology people with diabetes don’t have to book an additional appointment with a specialist for the service.
The trend
AI diagnostics are on the rise in the digital health space. Just yesterday digital pathology startup Proscia announced that it closed an $8.3 million Series A funding round. Additionally, in February Viz.ai's Contact, a clinical decision support tool that analyzes CT results and highlights cases that may have experienced a stroke, got the FDA nod to go to market. The product was also submitted through the FDA's De Novo premarket review platform, which created a new classification for similar AI-driven platforms.
IDx specifically has been gaining a lot of attention recently. In September the trial data that led to IDx’s De Novo approval was published in npj Digital Medicine. The 900-patient investigation showed that the IDx-Dr system “robustly exceeded the pre-specified primary endpoint goals” and is able to realistically be deployed and used by non-specialists providers. However, when these results were published they were met with skepticism from experts in the field. In a response to the published result, Dr. Pearse A. Keane, a clinician scientist at the National Institute for Health Research (NIHR), and Dr. Eric J. Topol, director of the Scripps Translational Science Institute and EVP at Scripps Research Institute, wrote an editorial which questioned the sampling limitations, protocol decisions, and specific clinical limitations. The pair called for more validation studies in the future.
Clincial decision support tools have also been in the FDA news a lot this year. Last fall the FDA proposed changes to the way clinical decision support tools are regulated, so that instead of a CDS device being regulated based on risk it will depend on the degree of human involvement. Under the new draft guidance, a CDS tool does not have to be regulated if a doctor can independently review and understand the basis of the software's decision.
On the record
“The healthcare industry needs to accelerate its adoption of AI to reduce costs and drive efficiencies,” said Sarah London, senior principal at Optum Ventures, the venture fund of Optum, a leading information and technology-enabled health services business and part of UnitedHealth Group. “We are confident that IDx will transform health care by increasing patient access to early disease detection, which is why we look forward to helping build a bridge between IDx and the physcians and patients who would benefit from adopting this system."
