After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.
Almost two years after publishing a controversial draft guidance on clinical decision support (CDS) software, the US Food and Drug Administration is taking another stab at the issue with an updated draft guidance to the delight of industry stakeholders.
On 26 September, the agency released the Clinical Decision Support Software guidance – a revised version of a document...
In this week’s Digital Health Roundup, Medtech Insight’s Ryan Nelson highlights Click Therapeutics’ FDA-cleared digital therapeutics (DTx) for depression and Sinaptica Therapeutics’ personalized neuromodulation for Alzheimer’s patients. Marion Webb discusses her interview with MindMaze’s John Krakauer on their gaming-focused DTx to help people recover from serious brain injuries. Elizabeth Orr introduces new voting members of the new Digital Health Advisory Committee and Natasha Barrow discusses Hello Heart’s new symptom-tracking feature in their heart-focused app.
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.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
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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.
Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
