Nearly 50% of FDA-Approved AI-based Medical Devices Are Not Trained Using Real Patient Data! – The Medical Futurist Newsletter

Medical devices on the dark web, diabetes wearables and top genomic companies. A great way to end the summer, I hope you are all ready for an exciting fall season. As a sign of that, I just had a [CNN interview]( about the future of healthcare. It will be out early October. Moreover, our benchmark [paper]( for medical futures studies got accepted by JMIR. I hope that this study marks a significant milestone towards recognizing medical futures studies as an independent discipline. And finally, [massage]( and [dentist]( robots everywhere! I hope you will find the newsletter useful! Best regards, Berci Bertalan Meskó, PhD The Medical Futurist [ALMOST HALF OF FDA-APPROVED AI MEDICAL DEVICES ARE NOT TRAINED ON REAL PATIENT DATA]( --------------------------------------------------------------- What a worrying finding: recent study has revealed that nearly half of FDA-approved AI medical devices have not been trained on actual patient data. "𝐴𝑙𝑡ℎ𝑜𝑢𝑔ℎ 𝐴𝐼 𝑑𝑒𝑣𝑖𝑐𝑒 𝑚𝑎𝑛𝑢𝑓𝑎𝑐𝑡𝑢𝑟𝑒𝑟𝑠𝑏𝑜𝑎𝑠𝑡 𝑜𝑓 𝑡ℎ𝑒 𝑐𝑟𝑒𝑑𝑖𝑏𝑖𝑙𝑖𝑡𝑦 𝑜𝑓 𝑡ℎ𝑒𝑖𝑟 𝑡𝑒𝑐ℎ𝑛𝑜𝑙𝑜𝑔𝑦 𝑤𝑖𝑡ℎ 𝐹𝐷𝐴 𝑎𝑢𝑡ℎ𝑜𝑟𝑖𝑧𝑎𝑡𝑖𝑜𝑛, 𝑐𝑙𝑒𝑎𝑟𝑎𝑛𝑐𝑒 𝑑𝑜𝑒𝑠𝑛𝑜𝑡 𝑚𝑒𝑎𝑛 𝑡ℎ𝑎𝑡 𝑡ℎ𝑒 𝑑𝑒𝑣𝑖𝑐𝑒𝑠ℎ𝑎𝑣𝑒 𝑏𝑒𝑒𝑛 𝑝𝑟𝑜𝑝𝑒𝑟𝑙𝑦 𝑒𝑣𝑎𝑙𝑢𝑎𝑡𝑒𝑑 𝑓𝑜𝑟 𝑐𝑙𝑖𝑛𝑖𝑐𝑎𝑙 𝑒𝑓𝑓𝑒𝑐𝑡𝑖𝑣𝑒𝑛𝑒𝑠𝑠𝑢𝑠𝑖𝑛𝑔 𝑟𝑒𝑎𝑙 𝑝𝑎𝑡𝑖𝑒𝑛𝑡 𝑑𝑎𝑡𝑎. 𝑊𝑖𝑡ℎ 𝑡ℎ𝑒𝑠𝑒 𝑓𝑖𝑛𝑑𝑖𝑛𝑔𝑠, 𝑤𝑒 ℎ𝑜𝑝𝑒 𝑡𝑜 𝑒𝑛𝑐𝑜𝑢𝑟𝑎𝑔𝑒 𝑡ℎ𝑒 𝐹𝐷𝐴 𝑎𝑛𝑑 𝑖𝑛𝑑𝑢𝑠𝑡𝑟𝑦 𝑡𝑜 𝑏𝑜𝑜𝑠𝑡 𝑡ℎ𝑒 𝑐𝑟𝑒𝑑𝑖𝑏𝑖𝑙𝑖𝑡𝑦 𝑜𝑓 𝑑𝑒𝑣𝑖𝑐𝑒 𝑎𝑢𝑡ℎ𝑜𝑟𝑖𝑧𝑎𝑡𝑖𝑜𝑛 𝑏𝑦 𝑐𝑜𝑛𝑑𝑢𝑐𝑡𝑖𝑛𝑔 𝑐𝑙𝑖𝑛𝑖𝑐𝑎𝑙 𝑣𝑎𝑙𝑖𝑑𝑎𝑡𝑖𝑜𝑛 𝑠𝑡𝑢𝑑𝑖𝑒𝑠𝑜𝑛 𝑡ℎ𝑒𝑠𝑒 𝑡𝑒𝑐ℎ𝑛𝑜𝑙𝑜𝑔𝑖𝑒𝑠𝑎𝑛𝑑 𝑚𝑎𝑘𝑖𝑛𝑔 𝑡ℎ𝑒 𝑟𝑒𝑠𝑢𝑙𝑡𝑠𝑜𝑓 𝑠𝑢𝑐ℎ 𝑠𝑡𝑢𝑑𝑖𝑒𝑠𝑝𝑢𝑏𝑙𝑖𝑐𝑙𝑦 𝑎𝑣𝑎𝑖𝑙𝑎𝑏𝑙𝑒." [READ MORE]( WHY DO I THINK IT'S IMPORTANT? Developing AI-based medical tools is quite a unique challenge. Without access to sufficient high-quality data, progress is hindered. However, the use of synthetic data, while a viable option, often faces criticism for not using real patient data. [HEALTHCARE ON THE DARK WEB: FROM FAKE DOCTORS TO FERTILITY DEALS]( --------------------------------------------------------------- According to widely available data, about 90% of the internet lies below the “visible” layer we interact with daily – beyond the reach of search engines like Google. This massive portion is called the deep web and contains databases, academic archives, and other data not indexed by standard search engines. From fake doctors to the trade of counterfeit medicines and the illegal trafficking of organs, there are significant threats to patients. As healthcare providers, it is crucial to be aware of these illicit activities. [READ MORE]( WHY DO I THINK IT'S IMPORTANT? Medical professionals and regulators must be aware of its dangers to avoid risks and educate patients. [A SHORT GUIDE TO GENERATIVE AI IN HEALTHCARE]( --------------------------------------------------------------- This 2024 fast-track course aims to provide a hands-on introduction to the world of generative AI - in just a few hours. If you want to learn about generative AI in an easygoing way, without committing substantial amounts of time, this is for you. Give it a try, and let us know, what you think! [ENROLL HERE]( [HUMAN BRAIN ORGANOID BIOPROCESSORS NOW AVAILABLE TO RENT FOR $500 PER MONTH]( --------------------------------------------------------------- FinalSpark just started offering paid ($500 per user per month) 24/7 remote access to its bioprocessors that are said to have million times greater power efficiency when compared to digital processors. It can also help save energy while training AI. "𝑇ℎ𝑒 𝑤𝑒𝑡𝑤𝑎𝑟𝑒 𝑎𝑟𝑐ℎ𝑖𝑡𝑒𝑐𝑡𝑢𝑟𝑒 𝑚𝑖𝑥𝑒𝑠ℎ𝑎𝑟𝑑𝑤𝑎𝑟𝑒, 𝑠𝑜𝑓𝑡𝑤𝑎𝑟𝑒, 𝑎𝑛𝑑 𝑏𝑖𝑜𝑙𝑜𝑔𝑦 𝑢𝑠𝑖𝑛𝑔 𝑎 𝑞𝑢𝑎𝑟𝑡𝑒𝑡 𝑜𝑓 𝑀𝑢𝑙𝑡𝑖-𝐸𝑙𝑒𝑐𝑡𝑟𝑜𝑑𝑒 𝐴𝑟𝑟𝑎𝑦𝑠(𝑀𝐸𝐴𝑠) ℎ𝑜𝑢𝑠𝑖𝑛𝑔 ℎ𝑢𝑚𝑎𝑛 𝑏𝑟𝑎𝑖𝑛 𝑜𝑟𝑔𝑎𝑛𝑜𝑖𝑑𝑠𝑖𝑛 𝑎 𝑚𝑖𝑐𝑟𝑜𝑓𝑙𝑢𝑖𝑑𝑖𝑐 𝑙𝑖𝑓𝑒 𝑠𝑢𝑝𝑝𝑜𝑟𝑡 𝑠𝑦𝑠𝑡𝑒𝑚.𝟥𝐷 𝑡𝑖𝑠𝑠𝑢𝑒 𝑚𝑎𝑠𝑠𝑒𝑠𝑎𝑟𝑒 𝑖𝑛𝑡𝑒𝑟𝑓𝑎𝑐𝑒𝑑 𝑎𝑛𝑑 𝑠𝑡𝑖𝑚𝑢𝑙𝑎𝑡𝑒𝑑 𝑏𝑦 𝑒𝑖𝑔ℎ𝑡 𝑒𝑙𝑒𝑐𝑡𝑟𝑜𝑑𝑒𝑠, 𝑤𝑖𝑡ℎ 𝑚𝑜𝑛𝑖𝑡𝑜𝑟𝑖𝑛𝑔 𝑐𝑎𝑚𝑒𝑟𝑎𝑠𝑎𝑛𝑑 𝑎 𝑡𝑢𝑛𝑒𝑑 𝑠𝑜𝑓𝑡𝑤𝑎𝑟𝑒 𝑠𝑡𝑎𝑐𝑘 𝑠𝑜 𝑡ℎ𝑎𝑡 𝑟𝑒𝑠𝑒𝑎𝑟𝑐ℎ𝑒𝑟𝑠𝑐𝑎𝑛 𝑖𝑛𝑝𝑢𝑡 𝑑𝑎𝑡𝑎 𝑣𝑎𝑟𝑖𝑎𝑏𝑙𝑒𝑠𝑎𝑛𝑑 𝑟𝑒𝑎𝑑 𝑎𝑛𝑑 𝑖𝑛𝑡𝑒𝑟𝑝𝑟𝑒𝑡 𝑝𝑟𝑜𝑐𝑒𝑠𝑠𝑜𝑟 𝑜𝑢𝑡𝑝𝑢𝑡." [READ MORE]( WHY IS IT IMPORTANT? The world’s first online platform delivering access to biological neurons in vitro! Maybe NVIDIA has a new competitor that develops human brain organoid-based processors? [THIS OVER-THE-COUNTER GADGET COULD HELP THE WAR AGAINST DIABETES]( --------------------------------------------------------------- An interesting insight on a diabetes wearable on the day when the FDA cleared the first device to enable automated insulin dosing for patients with type 2 diabetes. Victoria Song, a senior reporter focusing on wearables and health tech, tested The Dexcom Stelo, an FDA-cleared over-the-counter continuous glucose monitor for 2 weeks. 𝑇ℎ𝑒 𝑆𝑡𝑒𝑙𝑜, ℎ𝑜𝑤𝑒𝑣𝑒𝑟, 𝑖𝑠𝑎𝑖𝑚𝑒𝑑 𝑎𝑡 𝑇𝑦𝑝𝑒 𝟤 𝑑𝑖𝑎𝑏𝑒𝑡𝑖𝑐𝑠, 𝑠𝑝𝑒𝑐𝑖𝑓𝑖𝑐𝑎𝑙𝑙𝑦 𝑡ℎ𝑜𝑠𝑒 𝑤ℎ𝑜 𝑑𝑜𝑛’𝑡 𝑟𝑒𝑙𝑦 𝑜𝑛 𝑖𝑛𝑠𝑢𝑙𝑖𝑛. 𝑈𝑛𝑙𝑖𝑘𝑒 𝑇𝑦𝑝𝑒 𝟣, 𝑇𝑦𝑝𝑒 𝟤 𝑑𝑖𝑎𝑏𝑒𝑡𝑒𝑠𝑑𝑒𝑣𝑒𝑙𝑜𝑝𝑠𝑜𝑣𝑒𝑟 𝑡𝑖𝑚𝑒 𝑎𝑠𝑡ℎ𝑒 𝑏𝑜𝑑𝑦 𝑏𝑒𝑐𝑜𝑚𝑒𝑠𝑚𝑜𝑟𝑒 𝑖𝑛𝑠𝑢𝑙𝑖𝑛-𝑟𝑒𝑠𝑖𝑠𝑡𝑎𝑛𝑡. 𝑊ℎ𝑖𝑙𝑒 𝑠𝑜𝑚𝑒 𝑇𝑦𝑝𝑒 𝟤 𝑑𝑖𝑎𝑏𝑒𝑡𝑖𝑐𝑠𝑟𝑒𝑙𝑦 𝑜𝑛 𝑖𝑛𝑠𝑢𝑙𝑖𝑛, 𝑡ℎ𝑒 𝑣𝑎𝑠𝑡 𝑚𝑎𝑗𝑜𝑟𝑖𝑡𝑦 𝑚𝑎𝑛𝑎𝑔𝑒 𝑡ℎ𝑒𝑖𝑟 𝑏𝑙𝑜𝑜𝑑 𝑠𝑢𝑔𝑎𝑟 𝑤𝑖𝑡ℎ 𝑙𝑖𝑓𝑒𝑠𝑡𝑦𝑙𝑒 𝑐ℎ𝑎𝑛𝑔𝑒𝑠𝑎𝑛𝑑 𝑜𝑟𝑎𝑙 𝑚𝑒𝑑𝑖𝑐𝑎𝑡𝑖𝑜𝑛." [READ MORE]( WHY IS IT IMPORTANT? It could be a game changer because it could help pre-diabetic patients (about 100 million people only in the US!) to reverse their condition. [TOP COMPANIES IN GENOMICS]( --------------------------------------------------------------- From portable genome sequencers to genetic tests revealing distant relations with Thomas Jefferson, genomics represents a fascinatingly innovative area of healthcare. As the price of genome sequencing has been in free fall for years, the start-up scene is bursting with transformative power. Let’s look at some of the most amazing genomics companies! [READ MORE]( WHY DO I THINK IT'S IMPORTANT? Here are the leading companies across seven segments, from personal genomics to precision oncology and CRISPR. [HERE IS MEDSCAPE SCRIBE]( --------------------------------------------------------------- What an interesting development from Medscape : an AI assistant for clinicians for transforming patient notes into medical records. - Scribe is a HIPAA compliant AI tool that can listen to patient visits and create an EHR-ready summary. - Clinicians have 3 days to transform the notes into records. - The terms of use are clear about this not creating medical records while in fact that's what it does. - It only works in the US for now for clinicians with a Medscape account. - Clinicians can select from three commonly used summarization templates (SOAP, H&P, or POMR) [READ MORE]( WHY DO I THINK IT'S IMPORTANT? I hope some of you would test it so we could hear what it is like in action! 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