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How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, suggests clinical considerations for medical device developers and anticipates AI-enabled SaMDs’ future progress.
August 17, 2026
·
6 min read
·
JoAnne Bronikowski
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Femcare Ltd Acquires Orion Medical Supplies Ltd in the UK
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Microbot Medical® and Medtechnica Ltd. Enter into Three-Year Exclusive Distribution Agreement in Israel
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Three in Four FDA Authorizations of AI Medical Devices Were in Radiology, Study Led by GigHz Founder Finds
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Envoy Medical Hits Six-Month Milestone, Marks Halfway Point in Final Stage of Data Collection, and Highlights Differentiated Device Design
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Vocxi Health and Forj Medical Partner to Miniaturize Breath-Based Cancer Detection Device Platform
Advanced engineering collaboration accelerates development of MyBreathPrint™, a revolutionary Class II medical device platform that detects lung cancer and other diseases from a single minute of breathing
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New Cardiovascular Device Approved in Japan: Elixir Medical Announces Regulatory Approval of DynamX® Coronary Bioadaptor System
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