The marketing clearance follows the FDA’s decision to approve a “breakthrough device” designation for IDx-DR, accelerating the review process for the product based on its ability to address an unmet medical need....MobiHealthnews here. Medscape here. FDA press release here. Company website here.
“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered,” said Dr. Michael Abràmoff, founder and president of IDx, in a company news release. “Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”
On its website, the company writes: "IDx is developing algorithms that can detect disease across a number of imaging modalities, with a focus on fundus photography and optical coherence tomography (OCT). Current prototypes exist for macular degeneration, glaucoma, Alzheimer’s disease, cardiovascular disease, and stroke risk."
CMS Follows FDA.....
Reimbursement? Coverage? New Coding? RVU's? To be continued....
CEO Gary Seamans and I are both speaking (no relation) at the MedCity INVEST conference in Chicago May 1-2, 2018 - here.
IDX is based in Coralville, Iowa, on the other side of Des Moines from the farm where I grew up.