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Digital Health Series – Part 5: Key Challenges for Software and AI as a Medical…
In our previous posts, we explored software tools used in digital health and set the foundations around potential applications of…
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Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK
Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
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Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU
Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
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Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in…
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
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Digital Health Series – Part 2: Software as a Medical Device Regulated by the US…
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
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Digital Health Series – Part 1: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
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Are Registries the New “Gold Standard” ?
There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to…
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What are the reimbursement pathways for innovative digital health technologies?
Innovative digital health solutions are finding their ways into routine patient care in the US and Europe, and different payers…