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A Reuters report on botched surgeries involving AI-assisted medical devices is making the rounds, and it raises some genuinely uncomfortable questions.
Nuria and Morgan dig into the details: an AI navigation tool used in sinus surgery that allegedly failed to identify a patient's carotid artery, leading to a stroke, and an FDA report on AI software for prenatal ultrasounds wrongly labelling fetal structures.
Morgan brings her experience consulting for intraoperative AI companies to explain what these tools actually do, what the FDA approval pathway for AI add-ons to existing devices looks like, and why the story may be missing important context. They also talk about what FDA cuts and regulatory disruption mean for patient safety, and what questions you might want to ask before you go under the knife.
RESOURCES
Núria's website: nurianegrao.com
Morgan's website: morganleafemd.com
By AI RoundsA Reuters report on botched surgeries involving AI-assisted medical devices is making the rounds, and it raises some genuinely uncomfortable questions.
Nuria and Morgan dig into the details: an AI navigation tool used in sinus surgery that allegedly failed to identify a patient's carotid artery, leading to a stroke, and an FDA report on AI software for prenatal ultrasounds wrongly labelling fetal structures.
Morgan brings her experience consulting for intraoperative AI companies to explain what these tools actually do, what the FDA approval pathway for AI add-ons to existing devices looks like, and why the story may be missing important context. They also talk about what FDA cuts and regulatory disruption mean for patient safety, and what questions you might want to ask before you go under the knife.
RESOURCES
Núria's website: nurianegrao.com
Morgan's website: morganleafemd.com