Midas Touch or Fool’s Gold?
A regulatory science perspective on whether digital pathology can capture the US$223 billion digital health market
Richard Huang, Veronica Klepeis | | Longer Read
The world of healthcare has seen a technological explosion over the past few years – especially with respect to digital medical devices. But despite an estimated global digital health market of $223 billion by 2023 (1), digital pathology’s penetration into the space has been limited. Only a few of the artificial intelligence/machine learning (AI/ML)‐based medical devices approved by the US Food and Drug Administration (FDA) over the past several years have been in the digital pathology sphere (2). Now, the FDA has proposed new regulatory frameworks to account for the expected growth and iterative nature of AI/ML‐based medical devices (3) – and it’s vital that companies stay on top of the new regulatory paradigms so they can gain the necessary regulatory approvals to bring their products to market. After all, until a medical technology reaches the market, it cannot help real patients in real-world clinical settings.
Will digital pathology take advantage of this change and turn all that it touches into gold… or will it lose out on the quarter trillion‐dollar digital future?
Read the full article now
Log in or register to read this article in full and gain access to The Pathologist’s entire content archive. It’s FREE and always will be!
Or register now - it’s free and always will be!
You will benefit from:
- Unlimited access to ALL articles
- News, interviews & opinions from leading industry experts
- Receive print (and PDF) copies of The Pathologist magazine
Or Login via Social Media
By clicking on any of the above social media links, you are agreeing to our Privacy Notice.