Hardian team members Lucy Gregory (Health Economics Consultant) and Dr Felicity Lock (Senior Clinical Associate) recently returned from ISPOR Europe, an international conference in Glasgow dedicated to Health Economics and Outcomes Research. If ISPOR is unfamiliar territory, this overview explains why it should matter to anyone developing AI and software as a medical device.

MyCardium AI is a rapidly growing UK-based company delivering advanced core-lab services, now with two CE-marked and FDA-cleared AI medical devices - 1CMR Pro and EchoConfidence - built on decades of leading academic research. With Hardian Health as a strategic partner, MyCardium navigated complex regulatory pathways with exceptional speed and success. How did they do it?

For digital health innovators, the NHS can seem like a maze. It’s vast, decentralised, and full of confusing acronyms. But behind that complexity is a set of real people, teams, and incentives that, once understood, can help shape the routes to market access.

Many healthcare software products are described as “platforms.” But when it comes to Software as a Medical Device (SaMD), regulatory challenges quickly emerge. From classification to conformity assessments, platforms that host or enable MDSW apps—particularly those involving AI—must navigate complex and evolving frameworks across jurisdictions like the UK and EU.

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

Many startups rush to build products without deeply understanding NHS problems. This leads to poor adoption, even when the technology is strong. To succeed, you need to ensure your product solves a real NHS problem, one with clear unmet needs, decision-makers, and budget pathways.

Sanome has reached a landmark moment with the CE Marking of its AI-powered clinical decision support tool, MEMORI, as a Class IIb medical device. This makes it the first UK-built AI tool certified to tackle hospital-acquired infections—a major step forward for clinical AI and infection prevention.

SaMD regulatory requirements are fast evolving, with international efforts to harmonise frameworks still taking shape. Yet manufacturers must navigate jurisdiction-specific rules—especially as the US aligns more closely with ISO 13485:2016 in its Quality System Regulation. Whether you're targeting EU, US, or emerging markets, understanding the SaMD regulatory landscape is a critical first step.

Recently, we hosted an exclusive webinar featuring Dr Vera Roedel (CEO) and Professor Heinz Wiendl (Co-Founder) from Prof.Valmed®. They have achieved the significant milestone of securing the world's first regulatory clearance for a large language model (LLM) as a medical device.

Do AI medical devices need clinical data for CE mark? Many teams building AI that predicts, measures, prioritizes, or triages ask whether prospective clinical data is required under the EU MDR. Dr Ankeet Tanna outlines when clinical investigations are essential, when indirect clinical benefit and non‑clinical evidence can be enough.

Buying AI-triage software isn't like purchasing regular tech. These tools are medical devices with strict regulatory requirements. Our guide (co-produced with Visiba Group) breaks down everything you need to know…

From scribes and image analysis to triage, diagnosis, and treatment planning, the technical capability emerging from startups is already there. What’s less clear is a credible plan for how these tools will enter regulated clinical markets - and remain there.

While regulatory developments in the US, UK, and EU, such as the FDA’s AI January 2025 draft guidelines and the EU’s AI Act, have set prominent benchmarks, significant innovation and diverse regulatory strategies are evolving rapidly across Asia, Africa, and South America.

The clinical efficacy of AI applications in radiology has been well demonstrated in clinical studies. However, less is known about the potential impact beyond this. Specifically, changes in clinical decision making, patient referrals, patient visits, treatment costs …

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…

ISO and IEC standards are applicable to every industry, not just healthtech. But healthtech has its own standards that SaMD and AIaMD developers need to conform to.

Following on from previous blogs, What you need to know about traceable requirements for medical devicesand How much documentation does my Software as a Medical Device regulatory submission really need?, it’s time to now think about how to organise the complementary risk management, particularly for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

Anyone dealing with regulatory hurdles goes through the same 5 stages - denial, anger, bargaining, depression and acceptance. Here's how to smooth the journey.