Antonio Torres’ Post

EU publishes regulation governing use of AI in medical devices and IVDs Regulatory News | 15 July 2024 | Joanne S. Eglovitch The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing products on the market, and is the world’s first comprehensive AI law, according to the European Parliament.

This is the third in the series of Emergo by UL’s Regulatory Updates on the European Artificial Intelligence (AI) Act (AIA).   In this Regulatory Update we focus specifically on the AIA and penalties and timelines. We also include definitions which are salient to this and a Table (really more a visual representation) which outlines all the upcoming deadlines. Read the article (with our SME Sade Sobande, RAC) here: https://lnkd.in/gNGbzK9G. Article four is next. Stay tuned for a discussion on high risk medical device systems and the relationship of the European device regulations (Medical Devices Regulations/In Vitro Diagnostic Devices Regulations) and the AIA, as well as the opening of the EU AI office. Series on AIA:  *Regulatory Update 1: history, scope, classification, conformity assessment and operator’s obligations of AIA: https://lnkd.in/gKmePHMe . *Regulatory Update 2: AIA best practices, enforcement and oversight, and AI regulatory sandboxes and real-world testing: https://lnkd.in/g9r6q3_e . #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #AIA #nlf #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

https://buff.ly/3YeD9VK A recent article highlights the issue of FDA-approved AI devices lacking essential validation data, posing a significant challenge in the realm of clinical evidence for AI medical tools. The insufficiency of requisite validation data in numerous FDA-authorized AI devices has been brought to light, raising concerns about their efficacy and reliability in medical settings. This gap underscores the importance of stringent validation processes to ensure the accuracy and safety of AI technology in healthcare. #FDA #AIValidation

https://buff.ly/4ayoqrE The UK has outlined its stance on regulating AI as a medical device, with the MHRA stating that AI designed for medical purposes is highly likely to fit the criteria of a medical device. Currently, many AI products are categorized as low-risk, allowing them to enter the market without undergoing assessment by a notified body. However, the MHRA anticipates that numerous AI products will be reclassified to higher-risk categories under the new post-Brexit medical device regulatory framework. #MedicalDevices #AIRegulation

Free webinar 23JUL2024, 5 - 6:30 AM EDT. "Developers and manufacturers of AI medical devices are invited to hear early details of the MHRA AI Airlock project, which has been launched to help enhance understanding and accelerate solutions for the novel challenges of regulating AI medical devices. "The webinar will include presentations on the following topics: * the challenges of regulating AI medical devices: context and overview * an introduction to the aims and objectives of the AI Airlock project * opportunities and timelines for developers and manufacturers to get involved. "There will also be a Question and Answer session specifically aimed at answering questions from developers and manufacturers who are considering getting involved." #UK #MHRA #AI #AIAirlock #AIaMD https://lnkd.in/ghGmytEh

Check out the new #OSEL research pages covering the work we do on AI in medical devices ##CDRH #FDA #regulatoryscience #medicaldevices 

It's very exciting to see the AI in Medical Imaging Market growing as shown in the post from Amy Thompson at Signify Research Ltd ! I agree that we will continue to see substantial growth in Cardiology as well as many other areas in Medicine. It is also interesting to see the increasing number of applications that are "Standalone AI". When we started on this path at HeartFlow, Inc in 2010 building a standalone system and product there was some skepticism that this approach would be viable. Indeed, as time has proven, this approach enables easier access to data for training and improving A.I. algorithms as well as the opportunity for clinical focus and building relationships with healthcare providers.

FDA has approved over 950+ AI-based Medical Devices! Great to see so many are ready to be deployed clinically. Most of them are in imaging, aiding diagnosis, and to some extent workflow. (Radiologists are among the most expensive and overworked specialties). Most of them are also approved via 510(k) which among other things, doesn't require clinical trials (but still requires proof of safety and effectiveness). So far, no GenAI or LLM devices. How many are *actually* in widespread clinical use? Hard to say. Improving workflows and operational efficiency is much more likely in the short term than big changes in clinical practice. But the fact that the FDA has ramped up the amount of approvals completed, and specifying which devices are AI-based is huge progress. We're years away from computers diagnosing disease without human oversight. If you'll excuse me, I've got to get a $2 Rx that was handled by a $150k pharmacist. 😉 Seriously though, drop your comments below on this development. https://lnkd.in/ggTxNbhu

🚀 Check out Amy Thompson and the team’s great work on the latest "AI in Medical Imaging World Market Analysis 2024" report! For more insights into AI in medical imaging, reach out to Amy and her team!

The use of AI in the life science sector is vast and growing rapidly. Some key applications include:- 🧫🔬🔎 1. DRUG DISCOVERY 2. CLINICAL TRIAL 3. MEDICAL DEVICE DESIGN 4. DRUG DESIGN 5. PERSONALISED MEDICINE 6. DRUG REPURPOSING 7. BIOMARKER IDENTIFICATION 8. CHATBOTS AND VIRTUAL ASSISTANTS 9. MEDICAL IMAGING ANALYSIS 10. ELECTRONIC HEALTH RECORD (EHR) ANALYSIS. If you want to know how to Incorporate AI in these topic📝 Stay tuned📍 We have something exciting to share✨✔️ #lifescience #Ai #biotechtrek #session #bsc #msc #phd #postdoc #Industryexpert #incorporation #work