BLINKLAB - Neuro Behavioral Testing

$BB1 - Sarah Hughan covers BlinkLab in the Stockhead Road to 2025 video series. It’s been a big year for BlinkLab since its IPO in April, as it continues to develop digital diagnostic tools for autism, ADHD and other mental conditions. https://lnkd.in/ggKHU9GG $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

The recent RSNA meeting was truly impressive, highlighting the exciting advancements in artificial intelligence in healthcare. It's great to see that we now have a framework for the regulatory assessment of traditional AI/ML software as medical devices, which has led to an increase in the number of FDA-regulated devices. However, there are some important concerns that need to be addressed. Many companies are shifting their regulatory priorities to introduce new AI/ML devices in markets like the EU instead of the U.S., and they're putting their plans for the U.S. on hold. This is largely due to the challenges they face in the U.S. reimbursement landscape, which makes it hard for them to see sales potential here. While the FDA approval process can be tricky, the bigger issue seems to be the reimbursement process, which is often seen as a dead-end for new innovations. This is a serious problem that needs to be resolved quickly, as it could negatively impact public health and limit U.S. patients' access to these exciting new technologies. In my opinion, as a country known for its innovation and opportunities, the U.S. should ensure that its regulations encourage progress rather than hinder it, especially with all the amazing developments happening in technology, like generative AI. Perhaps it is the time for FDA to work with HHS and other regulatory bodies to address this issue by creating a more favorable environment for developing and reimbursing these groundbreaking technologies, ensuring that U.S. patients benefit from the latest advancements in healthcare.

BlinkLab has announced a positive outcome from a pre-submission meeting with the US Food and Drug Administration (FDA) to support the registration of its Dx 1 platform as an aid in the diagnosis of autism. https://lnkd.in/geJxa5A3 $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

BlinkLab Limited (ASX:BB1) is pleased to announce a positive outcome from its Pre-Submission meeting with the FDA yesterday Read more: https://lnkd.in/gVvxsff6 $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

BlinkLab (ASX:BB1) said analysis of a study conducted in 441 children diagnosed for autism using current standard-of-care protocols showed that the medtech’s BlinkLab Dx 1 platform detected autism with an improved sensitivity of 91% and specificity of 85%. https://lnkd.in/guRwEPau $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

Last month, investors connected with an exciting lineup of emerging ASX-listed resources, healthcare, and technology companies at the Sydney Opera House as part of the Jane Morgan Management (JMM) Sydney Lunch. BlinkLab Limited (ASX:BB1) is a trailblazer in digital healthcare, leveraging AI and machine learning in mobile applications to revolutionise neurodevelopmental condition diagnosis like ASD and ADHD. After successfully listing earlier this year, BlinkLab has rapidly expanded its strategic JVs and partnerships globally, providing a platform to commence FDA approvals before the end of 2024. View more from $BB1 Non-Executive Chairman Brian Leedman: https://lnkd.in/gKvWJvD7 $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

BlinkLab Limited (ASX:BB1) is excited to announce results from the latest study in autism confirming high-accuracy in detecting autism in children ahead of upcoming FDA registrational study.  Read more: https://lnkd.in/gX8RaRjR $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

BlinkLab will participate in the ‘landmark’ MAGNET (Monash Autism & ADHD Genetics and Neurodevelopment) project, an ongoing, study aiming to enrol 1000 families with children diagnosed with only autism, only ADHD, or both. https://lnkd.in/ggDz4EHC $BB1 Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

$BB1 - Stockhead's Fraser Palamara explains how BlinkLab Limited (ASX:BB1) is getting involved in a major autism and ADHD study with Melbourne’s Monash University – and what investors can expect from the company’s work. https://lnkd.in/gvFfMrhW Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks

BlinkLab Limited (ASX:BB1), an innovative digital healthcare company developing smartphone-based AI powered diagnostic tests for neurological conditions, is pleased to announce their participation in the landmark MAGNET (Monash Autism & ADHD Genetics and Neurodevelopment) study conducted by Monash University’s School of Psychological Sciences. Link: https://lnkd.in/gmtknJp5 Read more: https://lnkd.in/gZdKBtnk Henk-Jan Boele Brian Leedman Anton Uvarov PhD MBA Richard Hopkins #awareness #autismspeaks