November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
September 27, 2018
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...
August 28, 2018
Pivotal trial data that led to April’s de novo clearance of the first AI-based diagnostic system to not require clinician interpretation is now available to the public. Published today in npj Digital Medicine, this 900-patient investigation showed that the IDx-Dr system for autonomous detection of diabetic retinopathy “robustly exceeded the pre-specified primary endpoint goals” and is able to...
July 5, 2018
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.
In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
April 12, 2018
The FDA has granted diagnostics company IDx’s De Novo request to market its AI-based software system for the autonomous detection of diabetic retinopathy in adults who have diabetes, called IDx-DR.
This decision represents the first AI-based diagnostic system authorized by the FDA for commercialization in the US that can provide a screening decision without the need for clinician interpretation,...