The Current State Of Over 1250 FDA-Approved, AI-Based Medical Devices – This And More News In Digital Health This Week

The Current State Of Over 1250 FDA-Approved, AI-Based Medical Devices – This And More News In Digital Health This Week

Here is Economist Impact's new report looking at future adaptation strategies to minimise the impact of climate change on cardiovascular-renal-metabolic diseases. I had the chance to participate in the advisory panel through workshops to help form the final report. Such clearly described future visions are essential for healthcare leaders to better see where we are (or should be) heading!

I'm also testing a sensor for five days (with two chest patches) to measure heart rate variability, among other factors. After that, the company Fusion Vital provided a personal session to analyze the results. It helps me find out how much I stress, and how do I regenerate from that. I'll share more details in the upcoming article on medicalfuturist.com.

And finally, if you know someone building the future of healthcare with digital health or AI, please let me know. At The Medical Futurist, we’re looking for founders, innovators, and bold thinkers who are running valid, active businesses to feature in interviews on our channels. No stealth mode startups, please.

I hope you will find this newsletter useful!

Have a great week!

Best regards,

Berci

Bertalan Meskó, PhD

The Medical Futurist

THE CURRENT STATE OF OVER 1250 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 1250 approvals and clearances to date, indicating an acknowledgment of AI’s expanding role in healthcare.

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MEET YOUR DIGITAL TWIN: THIS AI MODEL CAN PREDICT YOUR FUTURE HEALTH

You can see a sensor or wearable providing data. You can see the results of a study analyzing how a certain AI can contribute to healthcare. But how can you demonstrate digital twins so everyone can understand what they are about? This new study doesn't solve that but definitely plays a role. The Human Phenotype Project collected extensive, in-depth medical information from over 13,000 people! You can see the sources of the data in the figure.

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YOUR MAP TO THE FUTURE

While the future is believed to be a fixed, singular path, in fact, multiple futures exist, and Your Map To The Future gives you the science-based tools to explore and prepare for them. With fresh perspectives, it illustrates why looking forward is crucial in addressing today’s most pressing issues, from climate change to artificial intelligence.

CHECK IT OUT

WHAT PHARMA EXECUTIVES SECRETLY THINK ABOUT THE FUTURE

From in-silico trials to 3D printed drugs, the future of the pharmaceutical landscape is set to look wildly different from just a few decades ago. Here is why.

WATCH IT

WHITE HOUSE LAUNCHES DIGITAL HEALTH INITIATIVE BACKED BY LEADING TECH FIRMS

"𝑇ℎ𝑒 𝑇𝑟𝑢𝑚𝑝 𝑎𝑑𝑚𝑖𝑛𝑖𝑠𝑡𝑟𝑎𝑡𝑖𝑜𝑛 𝑎𝑛𝑛𝑜𝑢𝑛𝑐𝑒𝑑 𝑊𝑒𝑑𝑛𝑒𝑠𝑑𝑎𝑦 𝑡ℎ𝑎𝑡 𝑖𝑡 𝑠𝑒𝑐𝑢𝑟𝑒𝑑 𝑡ℎ𝑒 𝑏𝑎𝑐𝑘𝑖𝑛𝑔 𝑜𝑓 𝑜𝑣𝑒𝑟 𝟨𝟢 𝑙𝑒𝑎𝑑𝑖𝑛𝑔 ℎ𝑒𝑎𝑙𝑡ℎ𝑐𝑎𝑟𝑒 𝑎𝑛𝑑 𝑡𝑒𝑐ℎ𝑛𝑜𝑙𝑜𝑔𝑦 𝑐𝑜𝑚𝑝𝑎𝑛𝑖𝑒𝑠 𝑓𝑜𝑟 𝑎𝑛 𝑖𝑛𝑖𝑡𝑖𝑎𝑡𝑖𝑣𝑒 𝑑𝑒𝑠𝑖𝑔𝑛𝑒𝑑 𝑡𝑜 𝑚𝑎𝑘𝑒 𝑝𝑒𝑟𝑠𝑜𝑛𝑎𝑙 𝑚𝑒𝑑𝑖𝑐𝑎𝑙 𝑑𝑎𝑡𝑎 𝑚𝑜𝑟𝑒 𝑎𝑐𝑐𝑒𝑠𝑠𝑖𝑏𝑙𝑒 𝑡𝑜 𝑈.𝑆. 𝑐𝑜𝑛𝑠𝑢𝑚𝑒𝑟𝑠 𝑣𝑖𝑎 𝑑𝑖𝑔𝑖𝑡𝑎𝑙 𝑑𝑒𝑣𝑖𝑐𝑒𝑠." The goal? “...so that patients have the information and resources they need to make better health decisions.”

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THE WORLD’S RICHEST WOMAN HAS OPENED A MEDICAL SCHOOL

The world’s richest woman and an heir to the Walmart fortune, Alice L. Walton, just opened a medical school with 48 students.

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FDA’S ARTIFICIAL INTELLIGENCE IS SUPPOSED TO REVOLUTIONIZE DRUG APPROVALS. IT’S MAKING UP STUDIES

This June, the FDA launched a generative AI assistant called Elsa, to help with tasks such as: summarizing adverse events for safety evaluations, reviewing clinical protocols, comparing drug labels or generating internal database code. But like every LLM, Elsa is hallucinating too.

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Dr. Chandra Shekhar Banerjee, Ph.D.

Healthcare / Pharmaceutical Consulting I Medical Education & Learning I Healthcare Research I Healthcare Digital & IT Solutions I Management Education I Professor

3d

AI’s growing role in healthcare is reshaping how we diagnose, treat, and care for patients on a deeply human level.

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Salome Nel

Clinical Project Manager | Driving Global Clinical Trials With Excellent Project Management Skills To Success | Championing patient-centric clinical trials to accelerate medical innovation

3d

Bertalan Meskó, MD, PhD thank you for sharing. I find it particularly compelling that AI's emergence in healthcare is transforming medical practice, bringing novel regulatory challenges as it continues to evolve - challengers that will demand robust oversight to manage emerging risks in the years ahead

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Raziq Ahmad Tariq

AI enthusiast | Digital Health | IT Manager @Lufthansa Medical Center

3d

Thanks for sharing. It’s a really good summary of the latest news!

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Mark Leaning, PhD

🩺Health Tech Innovator and Entrepreneur at Directed Systems Ltd. - Clinical Cardiovascular R&D and Medical Software | AI & Data Science | Revolutionizing Patient Outcomes in Anesthesia, Patient Care, Emergency Care

4d

🙏🙏🙏

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Gary Kauffman

I help Medical Professionals save on taxes through legal and ethical strategies.

6d

Thank you!

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