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AI Solutions Continue to Catch FDA & #039;s Eye
FDA has given a nod to yet another artificial intelligence (AI)-based technology. This time the agency has granted a De Novo request to market IDx’s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, which can lead to blindness. The Coralville IA-based company’s IDx-DR diagnostic received expedited review under the FDA's Breakthrough Devices program. Earlier this year, the company told MD+DI that it met its endpoints in a pivotal trial of the IDx-DR system. The trial involved 900 diabetes patients at 10 sites. The study was designed to evaluate the diagnostic accuracy of the technology in ...
Source: MDDI - April 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

Defining Innovation
What’s behind the record-breaking growth shared in EY’s 2019 “Pulse of the Industry” medtech report? Innovation, along with plenty of opportunities to solve some unmet needs. “We are at an awesome time in terms of innovation,” explained Ashley McEvoy, worldwide chairman, medical devices, Johnson & Johnson. Technology can now reach once-difficult-to-access anatomy, and miniaturization can enable earlier intervention, she pointed out as notable advances. McEvoy was part of EY’s “...
Source: MDDI - October 2, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Business Source Type: news