AI Screening System For Blindness Associated With Diabetes Gets FDA Nod
The US FDA has cleared an AI-based diagnostic from Israeli firm AEYE Health that screens for diabetic retinopathy, a leading cause of blindness.
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NuraLogix developed machine-learning models that use facial blood flow patterns to predict disease. The company plans to pursue US FDA de novo authorization for its blood pressure monitoring module first in 2023.
During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.
News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’
This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.