Here’s a List of 950 FDA Authorized AI-Enabled Medical Devices – This And More News In Digital Health This Week
Bertalan Meskó, MD, PhD
Director of The Medical Futurist Institute (Keynote Speaker, Researcher, Author & Futurist)
I was recently featured on CNN's 'Tomorrow Transformed,' a half-hour special about the future of healthcare. The episode explored innovative digital health technologies and wearables, and featured an impressive lineup of experts. They asked me to share my views and research about what we can expect to see in the next decade. It was really great to be able to contribute. I also collaborated with Dave deBronkart on a publication about the past 25 years of patient empowerment. This infographic provides a snapshot of the key milestones and events that have shaped patient empowerment into what it is today. I think patient empowerment is one of the most important topics we could talk about when it comes to the future of healthcare, and I hope you’ll find this infographic interesting. I hope you will find the newsletter useful!
THE CURRENT STATE OF ALMOST 950 FDA-APPROVED, AI-BASED MEDICAL DEVICES
The FDA, a global leader in healthcare regulation, is adapting its framework to include AI-based medical devices, with 950 approvals to date, indicating an acknowledgment of AI’s expanding role in healthcare.
Radiology leads in AI device approvals reflecting deep learning’s applicability in image-based diagnostics, while the 510(k) submission pathway is predominant due to its streamlined process for devices similar to existing ones.
EMERGENCY ROOM PATIENTS’ SCANS USED TO TRAIN AI WITHOUT THEIR KNOWLEDGE
This is how you alienate patients from enjoying the benefits of using AI in their care! For example, you give hundreds of thousands of chest x-rays to a health technology company without telling patients.
It's especially problematic as "𝐸𝑚𝑒𝑟𝑔𝑒𝑛𝑐𝑦 𝑠𝑒𝑡𝑡𝑖𝑛𝑔𝑠 𝑎𝑟𝑒 𝑜𝑛𝑒 𝑜𝑓 𝑡ℎ𝑒 𝑓𝑒𝑤 𝑠𝑖𝑡𝑢𝑎𝑡𝑖𝑜𝑛𝑠 𝑤ℎ𝑒𝑟𝑒 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠 𝑐𝑎𝑛 𝑏𝑒 𝑔𝑖𝑣𝑒𝑛 𝑝𝑟𝑜𝑐𝑒𝑑𝑢𝑟𝑒𝑠 𝑙𝑖𝑘𝑒 𝑎 𝑐ℎ𝑒𝑠𝑡 𝑥-𝑟𝑎𝑦 𝑤𝑖𝑡ℎ𝑜𝑢𝑡 𝑔𝑖𝑣𝑖𝑛𝑔 𝑝𝑟𝑖𝑜𝑟 𝑐𝑜𝑛𝑠𝑒𝑛𝑡. 𝑇ℎ𝑖𝑠 𝑚𝑖𝑔ℎ𝑡 𝑖𝑛𝑐𝑙𝑢𝑑𝑒 𝑐𝑜𝑛𝑑𝑖𝑡𝑖𝑜𝑛𝑠 𝑤ℎ𝑒𝑟𝑒 𝑎 𝑝𝑎𝑡𝑖𝑒𝑛𝑡 𝑖𝑠 𝑢𝑛𝑐𝑜𝑛𝑠𝑐𝑖𝑜𝑢𝑠 𝑜𝑟 𝑛𝑜𝑡 𝑖𝑛 𝑡ℎ𝑒 𝑟𝑖𝑔ℎ𝑡 𝑠𝑡𝑎𝑡𝑒 𝑜𝑓 𝑚𝑖𝑛𝑑 𝑡𝑜 𝑎𝑔𝑟𝑒𝑒 𝑡𝑜 𝑎 𝑝𝑟𝑜𝑐𝑒𝑑𝑢𝑟𝑒 𝑛𝑒𝑐𝑒𝑠𝑠𝑎𝑟𝑦 𝑡𝑜 𝑠𝑎𝑣𝑒 𝑡ℎ𝑒𝑖𝑟 𝑙𝑖𝑓𝑒 𝑜𝑟 𝑝𝑟𝑒𝑣𝑒𝑛𝑡 𝑠𝑒𝑟𝑖𝑜𝑢𝑠 𝑖𝑛𝑗𝑢𝑟𝑦."
TECHNOLOGIES SHAPING THE FUTURE OF PHARMA
This book explains how disruptive technologies and emerging trends such as robotics, artificial intelligence, 3D printing, precision medicine or patient design will impact the manufacturing and distribution of pharmaceuticals in order to prepare successfully for a better future of healthcare.
GERMAN BIONIC LAUNCHED THE NEW APOGEE+ POWER SUIT
A new exoskeleton that assists healthcare professionals in patient transfers from beds and wheelchairs, washing and dressing, and supporting procedures such as changing wound dressings or even during surgery.
German Bionic launched the new Apogee+ power suit, specifically designed for the healthcare sector. With significant advancements in strength and intelligence, it helps reduce fatigue and injury risks while boosting operational efficiency in hospitals and care homes.
RESEARCHERS CREATE ROBOTIC FINGER THAT COULD PERFORM MEDICAL EXAMINATIONS
Researchers in China have developed a soft robotic “finger” with a sense of touch that can perform routine doctor office examinations such as taking a patient’s pulse or checking for abnormal lumps (or even typing on a keyboard).
They plan to transform it into a "Robodoctor" that could use AI to diagnose conditions like breast cancer.
"𝐴𝑑𝑑𝑖𝑡𝑖𝑜𝑛𝑎𝑙 𝑠𝑒𝑛𝑠𝑜𝑟𝑠 𝑝𝑟𝑜𝑣𝑖𝑑𝑒 𝑒𝑣𝑒𝑛 𝑚𝑜𝑟𝑒 𝑓𝑙𝑒𝑥𝑖𝑏𝑖𝑙𝑖𝑡𝑦 𝑖𝑛 𝑡ℎ𝑒 𝑟𝑜𝑏𝑜𝑡𝑖𝑐 𝑓𝑖𝑛𝑔𝑒𝑟’𝑠 𝑗𝑜𝑖𝑛𝑡𝑠. 𝑇ℎ𝑒𝑦 𝑎𝑙𝑙𝑜𝑤 𝑡ℎ𝑒 𝑑𝑒𝑣𝑖𝑐𝑒 𝑡𝑜 𝑚𝑜𝑣𝑒 𝑖𝑛 𝑚𝑢𝑙𝑡𝑖𝑝𝑙𝑒 𝑑𝑖𝑟𝑒𝑐𝑡𝑖𝑜𝑛𝑠 𝑙𝑖𝑘𝑒 𝑎 ℎ𝑢𝑚𝑎𝑛 𝑓𝑖𝑛𝑔𝑒𝑟, 𝑠𝑜 𝑖𝑡 𝑚𝑎𝑦 𝑏𝑒 𝑟𝑒𝑎𝑑𝑦 𝑡𝑜 𝑝𝑒𝑟𝑓𝑜𝑟𝑚 𝑒𝑓𝑓𝑒𝑐𝑡𝑖𝑣𝑒 𝑎𝑛𝑑 𝑒𝑓𝑓𝑖𝑐𝑖𝑒𝑛𝑡 𝑚𝑒𝑑𝑖𝑐𝑎𝑙 𝑒𝑥𝑎𝑚𝑖𝑛𝑎𝑡𝑖𝑜𝑛𝑠 𝑖𝑛 𝑡ℎ𝑒 𝑛𝑒𝑎𝑟 𝑓𝑢𝑡𝑢𝑟𝑒, 𝑡ℎ𝑒 𝑡𝑒𝑎𝑚 𝑐𝑜𝑛𝑐𝑙𝑢𝑑𝑒𝑑."
WHAT DO DIGITAL BIOMARKERS MEAN?
The spread of wearable digital technologies in healthcare generating big data entailed the appearance of a new type of medical information.
They produce actionable insights into the biological state of individuals, just as “general” biomarkers, but are collected through digital tools.
MICROSOFT UNVEILS NEW HEALTHCARE AI TOOLS
Another tech giant is working hard to bring something in their AI portfolio to healthcare.
- foundation models for medical imaging
- a healthcare data analysis platform
- to build an AI documentation product geared toward nurses.
"𝐼𝑛 𝑜𝑛𝑒 𝑒𝑥𝑎𝑚𝑝𝑙𝑒, 𝑎 𝑑𝑜𝑐𝑡𝑜𝑟 𝑐𝑜𝑢𝑙𝑑 𝑎𝑠𝑘 𝑎𝑛 𝐴𝐼 𝑎𝑔𝑒𝑛𝑡 𝑡𝑜 𝑓𝑖𝑛𝑑 𝑐𝑙𝑖𝑛𝑖𝑐𝑎𝑙 𝑡𝑟𝑖𝑎𝑙𝑠 𝑓𝑜𝑟 𝑎 𝟧𝟧-𝑦𝑒𝑎𝑟-𝑜𝑙𝑑 𝑝𝑎𝑡𝑖𝑒𝑛𝑡 𝑤𝑖𝑡ℎ 𝑑𝑖𝑎𝑏𝑒𝑡𝑒𝑠 𝑎𝑛𝑑 𝑖𝑛𝑡𝑒𝑟𝑠𝑡𝑖𝑡𝑖𝑎𝑙 𝑙𝑢𝑛𝑔 𝑑𝑖𝑠𝑒𝑎𝑠𝑒.𝑇ℎ𝑒 𝑡𝑜𝑜𝑙𝑠 𝑐𝑜𝑢𝑙𝑑 𝑎𝑙𝑠𝑜 𝑏𝑒 𝑔𝑒𝑎𝑟𝑒𝑑 𝑡𝑜𝑤𝑎𝑟𝑑 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠. 𝐶𝑙𝑒𝑣𝑒𝑙𝑎𝑛𝑑 𝐶𝑙𝑖𝑛𝑖𝑐 𝑢𝑠𝑒𝑑 𝑡ℎ𝑒 𝑎𝑔𝑒𝑛𝑡 𝑠𝑒𝑟𝑣𝑖𝑐𝑒 𝑡𝑜 𝑏𝑢𝑖𝑙𝑑 𝑡𝑜𝑜𝑙𝑠 𝑡ℎ𝑎𝑡 𝑎𝑙𝑙𝑜𝑤 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠 𝑡𝑜 𝑎𝑠𝑘 ℎ𝑒𝑎𝑙𝑡ℎ 𝑞𝑢𝑒𝑠𝑡𝑖𝑜𝑛𝑠 𝑎𝑛𝑑 𝑛𝑎𝑣𝑖𝑔𝑎𝑡𝑒 𝑡ℎ𝑒 ℎ𝑒𝑎𝑙𝑡ℎ 𝑠𝑦𝑠𝑡𝑒𝑚’𝑠 𝑠𝑒𝑟𝑣𝑖𝑐𝑒𝑠, 𝑎𝑐𝑐𝑜𝑟𝑑𝑖𝑛𝑔 𝑡𝑜 𝑎 𝑠𝑝𝑜𝑘𝑒𝑠𝑝𝑒𝑟𝑠𝑜𝑛."
MORE NEWS ABOUT THE FUTURE OF MEDICINE
ROBOTS – A pharmacy robot in China
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2moBertalan Meskó, MD, PhD Thanks for this great post. It does mirror my experience of working with AI in e.g., radiology, which is probably the bigget application area, to date. Do you know what the FDA is doing on DTx (as stand alone prescriptions i.e., not coupled with a drug) and remote monitoring solutions? These solutions are approved and regulated by themselves, but also make use of different types of AI in the service.
Senior Contracts Administrator currently actively seeking re-employment
2moOn possibly a different angle, but with the same goal of patient empowerment, and by this I mean empowerment BEFORE THEY BECOME A PATIENT and in order to avoid / or to greatly delay becoming a patient in the first place, I would humbly propose the reading of the books 'Younger Next Year for Men / Women' by Chris Crowley and Henry S Lodge MD (New York Times Bestsellers some years back), both of which are sadly out of print but still available at certain bookshops, but which, in a very attractive and light-hearted style carry the very important message of a healthy lifestyle and how to live it.
Healthcare Futurist | Clinical Informatics | Bridging Clinical Expertise with Health IT | Health Informatics | Adrenaline Enthusiast
2moThank you, Bertalan Meskó, MD, PhD, for this insightful list of AI-enabled medical devices and key updates in digital health. It's impressive how rapidly AI is being integrated into healthcare, especially with nearly 950 FDA-approved devices. Rightfully so, patient empowerment is a crucial topic regarding the future of healthcare.
Driving Revenue Growth for Medical Practices | Business Development Manager at Medheave
2mouseful
Assistant Professor @ Eindhoven University of Technology | PhD in Philosophy
2moThis list is incredibly useful thank you!