First-Of-Its-Kind Autism Software Could Help Diagnose, Treat Children Faster: FDA

The US agency says a lack of specialists often lead to delays in diagnosing children and prevents them from getting much-needed help during a treatment time frame, which the new breakthrough device can help fix.

Smiling mother taking selfie with autistic son while sitting on sofa at home

The US Food and Drug Administration has authorized first-of-its-kind breakthrough medical software that could help diagnose children with autism spectrum disorder (ASD) early and get them therapy sooner. The software uses machine learning, and a combination of apps and specialists working remotely to give an initial assessment whether a child has ASD before being referred to a specialist.

Cognoa submitted a de novo application for its Canvas Dx in September 2020 and was granted marketing authorization on 2...

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MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

MI-PolicyAndRegulation (Free-1): Biliary Atresia Linked to Autism and Neurodevelopment Delays

 
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.

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Nancy Tests SPARC-931 Part 7

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