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 "?????????????????? ???????????????? ?????? ?????? ???? ????? ?????? ???????????????????? ????????? ???????????????? ?????? ???? ?????????? ???????????????????? ???????? ?? ????????? ??-?????? ????????????? ???????????? ?????????? ??????????????. ??????? ????????? ?????????????? ???????????????????? ????????? ?? ?????????????? ???? ?????????????????????? ???? ?????? ???? ????? ????????? ?????????? ???? ???????? ???? ?????????? ???? ?? ?????????????????? ?????????????????? ???? ???????? ????????? ???????? ???? ?????????????? ?????????????? ????????????."
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.
"???????????????????? ?????????????? ?????????????? ???????? ???????? ?????????????????????? ???? ????? ?????????????? ????????????’?? ????????????. ??????? ?????????? ????? ???????????? ???? ???????? ???? ???????????????? ???????????????????? ???????? ?? ????????? ????????????, ???? ???? ?????? ???? ?????????? ???? ?????????????? ?????????????????? ?????? ?????????????????? ?????????????? ???????????????????????? ???? ????? ???????? ????????????, ????? ???????? ??????????????????."
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.
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MORE NEWS ABOUT THE FUTURE OF MEDICINE
ROBOTS – ?A pharmacy robot in China
I help companies generate new revenue streams, new business opportunities and efficiencies with a strong focus on leveraging AI, GenAI, Data and Digital Technologies.
21 小时前Bertalan 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
1 天前On 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
1 天前Thank 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
1 天前useful
Assistant Professor @ Eindhoven University of Technology | PhD in Philosophy
1 天前This list is incredibly useful thank you!