Panoramic: Automotive and Mobility 2025
Medical Device Artificial Intelligence
From smartphones to self-driving cars, artificial intelligence (AI) influences nearly every aspect of modern life. Health care is no exception. Use of artificial intelligence systems promises better health care management for patients and faster, more accurate diagnoses for doctors. Companies pursuing AI technologies must realize that while the health care industry is embracing this technology, the regulatory landscape is still finding its footing. That’s where we can help.
Hogan Lovells has been at the forefront of medical device AI regulation. We have advised our clients on the clearance or approval of numerous medical devices that incorporate artificial intelligence algorithms. From analysis of medical imaging such as echocardiograms, computed tomography (CT), endoscopy, and skin photographs, to tissue histology and physiological data, such as electrocardiograms (ECG), these technologies have demonstrated enormous potential for health care. They are designed to screen for diseases, classify malignancies, and provide personalized treatment recommendations, among other things, often sooner than has been possible using traditional technologies.
At the same time, these products raise unique regulatory questions due to their iterative and potentially self-updating nature, which is incongruent with historical regulatory approaches. The use of machine or deep learning offers the opportunity for continual optimization of an algorithm as new training data becomes available; whereas traditional regulatory approaches have focused on frozen algorithms that require new clearance or approval if changes are made postmarket.
Our capabilities at a glance
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Judicial review wins
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Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Representative experience
Developed an innovative strategy for interacting with FDA allowing Viz.ai to gain a quick De Novo clearance for a novel Computer-Aided Triage and Notification Platform to identify Large Vessel Occlusion strokes in CTA imaging.
Successfully assisted IDx LLC to achieve De Novo reclassification from the FDA for the groundbreaking AI-based device IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.
Assisted CSD Labs in obtaining 510(k) clearance of eMurmur, an innovative, AI-based murmur detection software.
Advised Bay Labs in seeking 510(k) clearance for its EchoMD AutoEF software, which applies machine learning algorithms to process echocardiography images in order to calculate left ventricular ejection fraction.
Assisted numerous clients with novel medical devices featuring AI and machine learning algorithms in developing and gaining FDA alignment on creative regulatory strategies to bring these innovative products to market in the U.S.
Awards and recognitions
Band 1 for Healthcare and Healthcare: Pharmaceuticals/Medical Products - District of Columbia
Chambers USA
2020
Highly Recommended for FDA Medical Devices
LMG Life Sciences
2019
Regulatory Firm of the Year
LMG Life Sciences Awards
2018-2019
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