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Software Medical Devices
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A Pathway for Clinical AI Developers Opens: FDA Clears First Software as a Medical Device With Patient-Facing LLM
By Samuel C. Bernstein, Allyson M. Maur, Natalie Oehlers
On June 25, 2026, UpDoc Inc., a clinical AI company, announced that it received clearance from FDA for what the company describes as the first Software as a Medical Device…
Blog of Digital Law and New Technologies
Is my wellness application a medical device?
Wellness applications, longevity platforms, habit-tracking tools and artificial intelligence-based solutions that help users gain greater control over their health are becoming increasingly common. However, as these technologies incorporate new functionalities…
India Corporate Law
Medical Device As Software: Has CDSCO Guidance Changed The Rules?
By Biplab Lenin, Akshat Razdan, Yash Kataria
Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory…
The Legal Wire
TGA publishes report on regulation of medical device software including AI
The Therapeutic Goods Administration (TGA) of Australia has published its report titled “Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI)” which sets outs findings in…
BioSlice Blog
EU Medical Device Software: New guidance on placing software medical devices on the EU market
By Eftychia Sideri, Arnold & Porter
The recently published MDCG 2025-4 guidance provides important clarifications on how Medical Device Software (MDSW) apps should be made available via online platforms and on the role of these online…
Health Care Law Today
Software as a Medical Device (SaMD): Health Care Regulatory Considerations
By Thomas B. Ferrante, Rachel B. Goodman
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the…
Health Care and Life Sciences
FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices
By Dominick DiSabatino, Audrey Mercer, Julian Klein
On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response…
Health Care Law Today
IP Contracting Considerations for Software as a Medical Device (SaMD)
By Nicholas J. Zepnick, Eric L. Sophir, Austin J. Kim
Advancements in the medical device space are increasingly driven by integrations of software, oftentimes as the fruit of the symbiosis between engineers at software development firms working with clinicians at…
Health Care Law Today
Protecting Innovations in SaMD & Biomedical Applications
By Eric L. Sophir, Nicholas J. Zepnick, Austin J. Kim
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next…
Health Care Law Today
Software as a Medical Device: Challenges Facing the Industry
By Kyle Y. Faget, Nathan A. Beaver, Jessa Boubker
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies,…