As of January 2023, there are 521 artificial intelligence (AI) medical devices on the market in the US and most are imaging devices.
While the FDA first approved a clinical AI algorithm in 1995, the growth rate has been slow until recent years....
Report Finds Most FDA-Approved AI Devices Are Used For Imaging
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The pace of artificial intelligence development has accelerated in recent years and now most of the artificial intelligence devices approved by the FDA are imaging devices.
Keep up with the top medtech business and regulatory news.
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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.
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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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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.
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Children with biliary atresia (BA) exhibited neurodevelopmental deficits and increased autism traits, with earlier surgery linked to better general neurodevelopment.
