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.

Advertised as a 90 day process, we analysed the data to find out how long it really takes for manufacturers to receive their 510(k) clearance.

If you currently have a UKCA or CE marked medical device on the market you should anticipate unannounced audits to be conducted on your organisation. We explain what they are and how you should be preparing for them.

From ChatGPT to deepfakes, AI development is rapidly progressing. In reaction to the current landscape of AI the European Commission is setting a standard with its new approach to AI regulation through the introduction of the EU Artificial Intelligence Act.

The market launch of your AI product is a huge achievement. It is the point from which you should finally begin to enjoy returns on years of personal and financial investment. We take a look at best practice implementation strategy to ensure success.

We supported AlphaBiomics' co-founder and CEO, Anthony Williamson, to develop a go-to-market (GTM) strategy to help them bring precision medicine to chronic inflammatory diseases.

ISO standards are designed to help businesses ensure that their products and services meet a certain level of quality, safety, and effectiveness. Healthtech has its own standards that organisations may need to conform to, here are the ones that you need to know and where you can find them.