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.

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.

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.

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 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.

'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.

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.

Learn the five key questions you need to ask AI vendors, giving you the low-down on common marketing misunderstandings, statistical obfuscation, and creative stretching of medical device regulation.

For innovative health technology, the only route to market is regulatory approval. The only route to regulatory approval is clinical evidence. You’ll need experts in both.

Health tech has suddenly found its new focus in Coronavirus - but are we at risk of doing more harm than good by rushing to use unproven solutions? To avoid chaos in the aftermath, we should focus on tried-and tested tech, and only use novel solutions where need is deemed greater than the acceptable risk.

In this article, co-authored with researchers from Stanford, Segmed.ai and Hardian Health, we describe fundamental steps for preparing medical imaging data in AI algorithm development, explain current limitations to data curation, and explore new approaches to address the problem of data availability.

Open access, published in Radiology.

Led by Lord O’Shaughnessy and Lord Darzi this white paper from the Imperial Institute of Global Health Innovation reviews the current landscape for NHS data, and makes recommendations for government on how to involve the public in future initiatives to harness the value of their medical data for the benefit of the NHS.

How do you build an AI company in healthcare? What can AI in radiology actually do? What should it be doing? Are clinicians ever going to be replaced? What does the future look like in healthcare AI?

In this HS Health Tech podcast, James is joined by Dr. Hugh Harvey, Managing Director at Hardian Health.

Prof Maryann Hardy and Dr Hugh Harvey explore how the radiographer role might develop and change in response to the evolving capabilities of intelligent technologies, the opportunities adoption may bring, and the steps required to ensure that the radiography profession remains engaged and involved in the successful delivery and implementation of AI systems.