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Regulations for VR/XR in mental health
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 HLTH Europe
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.
How the UK can accelerate radiology AI adoption
It’s no secret that the deployment of artificial intelligence in radiology is lagging behind expectations. Discover five ways AI adoption can be accelerated.
Hardian joins £20m 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.
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 to Level Up to Digital Therapeutics 2.0
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.
How to get ChatGPT regulatory approved as a medical device
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.
5 questions you need to answer to get your digital health or AI software product to US market quicker
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.
All I Want for Christmas is… Reliable AI
AI-enabled health tech has had its share of ups and downs over the past few years. Hardian breaks down the obstacles and solutions to moving the space forward.
NICE ESF & Hardian: The perfect recipe for bringing healthtech to market
TLDR: NICE ESF is a set of standards that digital health technologies should adhere to to be commissioned by the NHS and care system. Set yourself and your solution up for success by using ESF as a guide to demonstrate the clinical effectiveness and cost-benefit evidence ready for NICE health technology assessment (HTA).
A guide to FDA Diagnostic Radiology Product Codes
When it comes to the US market, three-letters stand in the way of getting your products to market. FDA Product Codes are essential in understanding and classifying your medical device. We breakdown FDA product codes for diagnostic radiology AI devices currently available on the market.
Hardian Health Tech Summit: Lifting the veil on the realities of getting healthtech to market
To celebrate four years of client service, we held our very first Hardian Health Tech Summit event. Joined by many of our clients changing the game in the healthtech industry and keynote speakers from MHRA and NICE, we brought together a community of healthtech leaders for everyone to connect, share and learn.
Literature Reviews Made Simple
Whether you are a clinician, academic, or work in healthtech, systematic literature reviews can be an intensive task. We empathise with you! Find out more on best practices and strategies.
NICE ESF: The what, when and how?
The UK's National Institute for Health and Care Excellence (NICE) released the latest evidence standards framework (ESF) for digital health technologies (DHTs). It's easy to see how standards updates can be confusing, however this update is an important one, and benefits everyone across the industry, from developers, through to healthcare services and patients.
Autonomous Radiology AI - too good to be true?
Autonomous AI is finally here - or is it? A recent breakthrough IIb regulatory approval raises questions, and perhaps sets the scene for upcoming legislative changes to how healthcare is practiced.
Re-imagining information and outcomes in healthcare
'Personalised medicine' is accelerating in clinical interventions (e.g. in genomics, pharmaceuticals, surgical implants and synthetic organoids). Now it's time to think about 'personalised medicine' in terms of the data we use to make clinical decisions and measure outcomes.
Tools for AIaMD Transparency and Reporting
Transparency around AI is the first step to building trust, but we still have some way to go to earning that trust in medical AI.