The rise of generative AI and large language models (LLMs), such as ChatGPT, has generated considerable excitement and investment in their potential medical applications. Despite the hype, this enthusiasm has yet to be matched with the level of scientific evidence needed to ensure these technologies are deployed in healthcare safely.

As AI continues to innovate, we regularly hear about new models being developed, tested and advertised for medical purposes without regulatory certification. The radiology AI space, now the most saturated of all FDA cleared AI enabled medical devices, also faces this issue so you might ask yourself, how can you access AI models, easily, and securely, which are certified?

During my recent chat on The Healthtech Podcast, I spoke candidly about the important aspects of health economics and why technologies (especially AI), need meticulous evaluation to ensure not only patient safety, but value for money.

In the fiercely competitive world of medtech, your bright idea is not just vulnerable; it's at risk of being snatched away. In this blog, we share why protecting your intellectual property (IP) becomes your superhero cape.

With Hardian Health’s support, Envisionit Deep AI® became the first ever African-founded company to receive FDA clearance for an AI device. In this article, we share Envisionit’s journey to 510(k) clearance.

One question we at Hardian get asked a lot is how to classify products for regulatory purposes that take an input from a sensor, and then process that signal using software. The answer depends on the intended purpose of the sensor, and the intended purpose of the output.

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

Launching an AI medical device startup is an adventure but with escalating costs threatening to slow your progress, the path to your first sale appears steep. We look at how you can get reimbursement for your AI medical device before regulatory approval.

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.

Learn how to derive the documentation requirements for SaMD from the safety and risk class of the device and download a free cheat sheet to help you navigate regulatory submissions.

Through our extensive experience of regulatory submissions for SaMD the top five make-or-break success factors are Design Control, Requirements Management, Risk Management, Verification and Validation evidence, and Software Maintenance under Change Control.

Software as a Medical Device is getting easier to build. Because of this many hospitals and other healthcare providers are now developing their own software and AI medical devices in-house to serve their patients. Learn how health institution exemptions might apply to your in-house SaMD or AIaMD in Great Britain.

In recent months The National Institute of Health Care and Excellence (NICE) have released several key guidances on the use of AI in the UK. The recommendations made in these highlight the current position that many companies with AI technologies as a medical device (AIaMD) find themselves in. That is, a need to demonstrate why health systems need them. We take a look at why this is so important.

After investing significant amounts of time, capital, and resources into your healthcare innovation, the crucial next phase is to secure its market success. In this article, we take a look at the building blocks of a strong market strategy.

Wearable devices, such as bracelets, patches, smartwatches, and virtual reality goggles are taking center stage in the digital healthcare revolution. In this article we take a look at how wearables and associated apps are regulated in the EU.

In the medical device industry, the role of intellectual property cannot be overstated. Whether you're a founder of a medical device company or a professional in the field, understanding and protecting your IP is critical for the growth and sustainability of your business.

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