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Blinklab Limited ( (AU:BB1) ) has issued an announcement.
BlinkLab Limited has announced the engagement of The Vanderbilt Kennedy Center as the seventh clinical research site for its FDA 510(k) diagnostic trial aimed at autism spectrum disorder. This partnership marks a significant step in the main study phase of the trial, which follows the completion of the pilot phase. The study is expected to be completed by the second quarter of 2026, with the final submission to the FDA anticipated in the third quarter of 2026. The addition of The Vanderbilt Kennedy Center, a renowned institution in developmental disabilities research, underscores BlinkLab’s commitment to robust and diverse data collection, enhancing the credibility and potential impact of its diagnostic tool. This strategic move is expected to maintain the momentum of the trial, ensuring the company’s adherence to its planned timeline for FDA submission.
More about Blinklab Limited
BlinkLab Limited is a leading digital healthcare company that focuses on AI-powered diagnostics. The company is currently working on gaining FDA 510(k) clearance for its smartphone-based diagnostic tool, BlinkLab Dx 1, which is designed to assist in the detection of autism spectrum disorder (ASD).
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Technical Sentiment Signal: Buy
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