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.

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 can damage trust and trigger regulatory scrutiny. Learn how to communicate evidence responsibly and build credibility.

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?

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?

Around a quarter of doctors are already using generative AI. But are they using it safely? Here's what healthcare professionals need to know.

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…

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.

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.

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 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.

It’s no secret that the deployment of artificial intelligence in radiology is lagging behind expectations. Discover five ways AI adoption can be accelerated.

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.

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.

We hosted our second annual Healthtech Summit, bringing together a diverse community of healthtech leaders to share their stories and learn from each other.

Health technology suffered several setbacks the last few months, culminating with Pear Therapeutics recently filing for bankruptcy. Now it’s time to take stock, regroup and work to usher in the next generation of digital therapeutics.

The advent of ChatGPT and similar large language models has created unprecedented excitement for their application in medicine. We explore how it might be possible to use LLMs such as ChatGPT in medical practice under current medical device regulatory frameworks.

When it comes to taking health innovation to the US, digital health companies need to be armed with robust clinical evidence to achieve approval from the Food and Drug Administration (FDA). We share 5 questions that you need to consider from the offset, that will maximise your chances of securing FDA regulatory approval and landing your product on US soil faster.