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BlinkLab Advances FDA Autism Diagnostic Trial with US Ethics Nod
8:50am on Monday 30th of June, 2025 AEST
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Healthcare
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BlinkLab Advances FDA Autism Diagnostic Trial with US Ethics Nod
8:50am on Monday 30th of June, 2025 AEST
Key Points
IRB approval obtained from WCG for main FDA 510(k) trial phase
Trial to enroll up to 1,000 participants across multiple US clinical sites
Study classified as minimally invasive, exempting most IDE regulations
At least eight autism centers expected to join the trial
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