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Reflections from HLTH Europe
Reflections from the Hardian team following the inaugural HLTH Europe conference in Amsterdam. Europeโs largest health innovation event definitely brought the Vegas vibes across the pond but if you didnโt make it this year, hereโs a roundup of five of our key takeaways.
High hopes and hard truths about AI in healthcare
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.
When does a radiology AI marketplace need regulatory certification?
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?
How an AI triage radiology service gained FDA clearance
With Hardian Healthโs support, Envisionit Deep AIยฎ became the first ever African-founded company to receive FDA clearance for an AI device. In this article, we share Envisionitโs journey to 510(k) clearance.
How to classify medical signal or image analyser software
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.
How to get reimbursement for your AI medical device before regulatory approval
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.
Hardian joins ยฃ20m 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.
How much documentation does my Software as a Medical Device regulatory submission really need?
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.
Critical success factors for a Software as a Medical Device regulatory submission
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.
Health Institution Exemptions for SaMD in Great Britain
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.
How to get wearables and companion apps regulatory approved
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.
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.
How long does an FDA 510(k) submission for SaMD and AI actually take?
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.
Making the Unexpected Expected: A Foundersโ Guide to Unannounced Audits
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.
What does the EU AI Act mean for the future of AI regulation?
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 ISO standards you need to know for SaMD and where to find them.
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.
Is the US 510(k) process robust enough for AI?
Substantial equivalence of AI systems cannot be reliably proven through technological, safety nor effectiveness characteristics, so is the US 510(k) process robust enough for AI?