Sanome's MEMORI: First UK AI tool for hospital infections certified

Bringing an AI-enabled SaMD (Software as a Medical Device) to market can still take up to five years, and much of that time is legitimately spent proving safety and efficacy. But not every delay is inevitable. In this post, I’ll map the end-to-end SaMD timeline and highlight a few places where AI can responsibly compress cycles without cutting corners on clinical rigor.

Checkpoint's latest partnership with Upheal isn't slowing down! We are thrilled to share this ethical, compliant, and time-saving AI-assisted notes system with all of our providers. Curious how this powerful integration can enhance the efficiency AND efficacy of your clinical operations? Learn more in our latest collaborative article with Upheal here 👉 https://lnkd.in/en_Jf6w7

📣NEW IMDRF Consultation on Predetermined Change Control Plans (PCCPs): The International Medical Device Regulators Forum (IMDRF) has released a draft guidance on Predetermined Change Control Plans (PCCPs) — now open for public consultation. This is an important step toward global alignment in managing planned software changes, particularly for AI/ML-based SaMD. The document outlines essential principles, core elements, and practical considerations for implementing a PCCP, while also addressing its potential benefits and challenges. I see this as a pivotal move toward enabling innovation without repeated re-submissions. 🗓️ Consultation closes December 8 — a great opportunity for stakeholders to review and provide input before finalization. 🔗 Read the full consultation here: https://lnkd.in/dtVVe5W9

Summary from Question No.22: Clarified timeframe for interim limits during CAPA implementation Temporary “above-AI” (Acceptable Intake) limits allowed only during CAPA implementation. These interim limits are strictly time-bound and must expire once CAPAs are complete. Final product compliance must meet approved AI limits. Authorities may require updates to shelf-life, storage conditions, or specifications to ensure compliance.

💡 Ever wondered how we can test medicine safety without putting humans or animals at risk? Here’s a glimpse into StopTox – a smart digital tool that predicts a drug’s toxicity in silico (on the computer 💻) before it reaches the lab. Safer, faster, and more ethical drug discovery starts here. 🌍✨ #DrugSafety #Innovation #StopTox #ScienceForAll

At Exafield, we know that the reliability of data is the foundation of meaningful market research. That’s why we’ve implemented an advanced anti-fraud process that enables us to verify patients and HCPs on multiple levels.   Our anti-fraud process includes, among other things: ✅ thorough verification of physician and patient data, ✅ confirmation of document and prescription authenticity, ✅ analysis of photos of medicines and medical devices, ✅ checking HCP profiles in databases such as PubMed, ClinicalTrials.gov, ✅ IP, VPN, and CAPTCHA monitoring to prevent misuse.   It’s a challenge — but it’s exactly what allows us to deliver market research of the highest quality to our clients.

107,500 pages — That's how many printed pages there were for this regulatory submission in 1988. 🫣 With the advent of new technology and AI, the industry is reducing the time the regulatory process can take...and the amount of paper. 💻Parexel, in partnership with Weave, a pioneer in AI-native regulatory automation management solutions, has been able to complete IND submissions 50% faster than traditional IND authoring timelines. This partnership advances Parexel’s vision to leverage AI to speed clinical research processes, enhance first-time quality and accelerate the delivery of life-changing therapies to patients.🫶 Read the full release here➡️https://lnkd.in/eVUMtsKq Photo courtesy of DIA

107,500 pages — That's how many printed pages there were for this regulatory submission in 1988. 🫣 With the advent of new technology and AI, the industry is reducing the time the regulatory process can take...and the amount of paper. Parexel, in partnership with Weave Bio, a pioneer in AI-native regulatory automation management solutions, has been able to complete IND submissions 50% faster than traditional IND authoring timelines. This partnership advances Parexel’s vision to leverage AI to speed clinical research processes, enhance first-time quality and accelerate the delivery of life-changing therapies to patients.🫶 Read the full release here➡️https://lnkd.in/eVUMtsKq

🚨 𝐄𝐚𝐫𝐥𝐲 𝐀𝐥𝐞𝐫𝐭𝐬 𝐌𝐚𝐭𝐭𝐞𝐫 – 𝐖𝐡𝐞𝐭𝐡𝐞𝐫 𝐟𝐫𝐨𝐦 FDA 𝐨𝐫 𝐃𝐚𝐭𝐚 𝐒𝐜𝐢𝐞𝐧𝐜𝐞 🚨 The FDA just announced it will expand Early Alert Communications across all medical devices on 9/29/2025, ensuring the public and healthcare providers receive faster warnings about potential high-risk recalls. The goal is clear: shorten the time between risk detection and action. At AlphaSPIKE, we are building in the same spirit—leveraging AI + advanced statistics to continuously monitor MDR complaint data at scale. By detecting spikes, deviations, and outliers in FDA adverse event reports, AlphaSPIKE acts as an “early radar” for product safety signals. Where traditional systems can lag or get overwhelmed, our platform transforms raw MDR data into actionable intelligence, revealing risks weeks before they escalate into recalls or enforcement actions. This alignment with the FDA’s vision reinforces a broader truth: early warnings save lives and protect trust. Just as FDA’s alerts empower clinicians and patients, AlphaSPIKE empowers manufacturers, investors, and regulators with the same edge—statistical foresight into emerging safety issues. The earlier you see the cracks, the sooner you can act. www.fdarisk.com #quality #risk #ai #cloudcompute #fda

Do these slides look identical? That's the point. One is a chemical stain and one is a virtual stain. Our AI models learn staining patterns directly from paired slides, preserving tissue integrity and delivering diagnostic-quality visuals in minutes. 💡 See how virtual staining compares for yourself. Link in the first comment. For Research Use Only. Not cleared or approved by the FDA. #VirtualStaining