Insights
Why Intended Clinical Benefits Fall Short in the Real World
Fundamental to all medical devices is the intended benefit they claim to offer to the end users, which manufacturers define at the very start of the regulatory pathway. More medical device software tools are being produced with the goal of reducing physician burnout, streamlining administrative tasks and speeding up diagnosis. But these claims often go unrealised in practice.
Clinician in the AI Loop: a faulty solution to a thorny problem
The vast majority of AI medical devices rely on having a clinician verify their outputs. On the surface this seems good for safety, but in reality it’s a short-sighted solution to a much deeper problem.
From AI regulation to NHS adoption: Insights from Hardian Health Tech Summit 2026
From AI regulation to NHS adoption, here are the biggest insights from Hardian Health Tech Summit 2026 and what they mean for HealthTech companies.
Do I need to notify the MHRA about my clinical investigation?
Do you need MHRA Notice of No Objection for your SaMD study? Learn when NoNo is required, how to apply, and what documentation regulators expect.
7 Practical Ways a Literature Review De-Risks an SaMD Pivotal Clinical Study
A strong literature review shapes SaMD study design, from comparators to sample size. Learn how it reduces risk in pivotal clinical studies.
Science Washing in Digital Health: How to Communicate Evidence Responsibly
Science washing in digital health can damage trust and trigger regulatory scrutiny. Learn how to communicate evidence responsibly and build credibility.
Blood pressure, wearables, and FDA General Wellness Guidance: did the rules really change?
In July 2025, the FDA issued a warning letter to WHOOP, stating that measuring blood pressure is a medical device function. But in January 2026, they updated their guidance. What changed? Do the new guidelines really allow wearables to measure blood pressure without regulation or evidence?
The FDA’s 2026 Clinical Decision Support (CDS) Guidance Update - What’s Changed?
It’s been 4 years since the FDA updated their CDS guidance. The new 2026 version brings clarification, more examples, and some pragmatic relaxation of how to interpret the CDS criteria. But are the changes really that substantial?
What to look out for if you are a doctor using Generative AI in clinical practice
Around a quarter of doctors are already using generative AI. But are they using it safely? Here's what healthcare professionals need to know.
CORE–MD: A Path to Clearer AI Device Evidence Standards?
One of the most common questions our clients ask us is deceptively simple: "What level of evidence do we need for regulatory approval for our AI tool?" The answer isn’t always clear…
Regulation of Digital Mental Health Technologies
As the use of digital tools in the mental health sector grows, so too does the need for clear and risk-proportionate regulation to ensure the safety and effectiveness of devices on the UK market. New guidance on Digital Mental Health Technologies (DMHTs), released by the MHRA in February, is a pivotal output of a 3 year collaborative project between the MHRA and NICE, funded by the Wellcome Trust.
What you can and can't say about your AI medical device
In an industry where patient safety and regulatory compliance are non-negotiable, making unverified or misleading claims isn’t just bad practice – it can lead to hefty fines, product recalls, and serious reputational damage.
Regulations for VR/XR in mental health
Find out how Hardian is supporting Innovate UK’s Mindset Extended Reality (XR) for digital mental health programme as part of Health Innovation Network (HIN) South London’s consortium of experts.
Reflections from HLTH Europe
Reflections from the Hardian team following the inaugural HLTH Europe conference in Amsterdam. Europe’s largest health innovation event definitely brought the Vegas vibes across the pond but if you didn’t make it this year, here’s a roundup of five of our key takeaways.
How the UK can accelerate radiology AI adoption
It’s no secret that the deployment of artificial intelligence in radiology is lagging behind expectations. Discover five ways AI adoption can be accelerated.
Hardian joins £20m Immersive Technology fund for mental health therapeutics
The new MindSet XR ecosystem for UK innovators working on immersive digital mental health therapeutics has been launched, including Hardian Health as a regulatory partner.
How To Conduct Due Diligence On SaMD And AIaMD Acquisitions
Expertise is needed to conduct thorough due diligence in the highly regulated and evidence-based healthcare sector. Hardian covers key clinical and regulatory points when conducting DD for investors, mergers, or acquisitions of an SaMD or AIaMD company.
AI, Innovation and Regulation: Solving Healthtech Puzzles at the Hardian Healthtech Summit
We hosted our second annual Healthtech Summit, bringing together a diverse community of healthtech leaders to share their stories and learn from each other.