BlinkLab Completes U.S. Clinical Trial Network for Pivotal FDA Study
BlinkLab Limited (ASX: BB1) has finalised the clinical site network for its pivotal FDA 510(k) study evaluating BlinkLab Dx 1, a smartphone-based diagnostic support tool designed to assist in detecting autism. The University of Arkansas has joined as the tenth and final clinical site, completing a network of leading autism research centres across the United States.
The study will enrol a minimum of 528 children aged between two and eleven years and aims to assess both the usability and diagnostic accuracy of the technology. Preparations are underway to begin patient recruitment, with testing expected to start later in March 2026.
The pivotal study follows earlier pilot research in the U.S. involving 485 children, where the technology demonstrated sensitivity of 83.7% and specificity of 84.7%, exceeding the performance benchmarks agreed with the FDA. Completion of the clinical network strengthens the regulatory pathway as BlinkLab advances the development of its AI-driven digital diagnostic platform.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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BlinkLab Completes U.S. Clinical Trial Network for Pivotal FDA Study
BlinkLab Limited (ASX: BB1) has finalised the clinical site network for its pivotal FDA 510(k) study evaluating BlinkLab Dx 1, a smartphone-based diagnostic support tool designed to assist in detecting autism. The University of Arkansas has joined as the tenth and final clinical site, completing a network of leading autism research centres across the United States.
The study will enrol a minimum of 528 children aged between two and eleven years and aims to assess both the usability and diagnostic accuracy of the technology. Preparations are underway to begin patient recruitment, with testing expected to start later in March 2026.
The pivotal study follows earlier pilot research in the U.S. involving 485 children, where the technology demonstrated sensitivity of 83.7% and specificity of 84.7%, exceeding the performance benchmarks agreed with the FDA. Completion of the clinical network strengthens the regulatory pathway as BlinkLab advances the development of its AI-driven digital diagnostic platform.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au