You may be interested in attending the FDA Virtual Public Workshop, “Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices,” planned for October 14, 2021.   Info on attending:  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-workshop-transparency-artificial-intelligencemachine-learning-enabled-medical-devices  
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Jonathan Zittrain and John Bowers of the Berkman Klein Center; Samuel Finlayson, Zachary Kohane, and Andrew Beam of Harvard Medical School; and Joichi Ito of the MIT Media Lab have published an article in Science highlighting potential uses of adversarial attacks on machine learning systems in the medical context.
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This July 2021 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices.  In addition to information on existing standards, our report keeps you...
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In 2018, Google Health began a program in Thailand to screen for diabetic retinopathy using artificial intelligence (AI). The AI was designed to analyze photos of diabetic patients’ eyes to detect signs of eye disease. The AI was promising in theory – during testing, it was 90% accurate in detecting diabetic retinopathy in eye scans,...
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On July 16, 2020, FDA issued 510(k) Approval for AI Imaging Analytics Device HealthMammo, a device manufactured by Zebra Medical Vision Ltd. As reported in the New York Times, HealthMammo is an artificial intelligence (AI) product that analyzes mammograms for suspicious lesions. Radiologists can use the HealthMammo results to prioritize which mammogram images need attention...
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On February 25-26, 2020 the U.S. Food and Drug Administration (FDA) held a public workshop to discuss the “Evolving Role of Artificial Intelligence in Radiological Imaging.” The comment period for the public workshop is extended to June 30, 2020, in response to requests for an extension to allow stakeholders additional time to submit comments.
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FDA Regulation of Artificial Intelligence (AI) and Machine Learning in Software as a Medical Device On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” that describes the FDA’s foundation for a...
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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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