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Principles of Good Machine Learning Practices for Medical Device Development For my colleagues in the AI/ML space, IMDRF (International Medical Device Regulators Forum) has opened comments on their 10 principles of Good Machine Learning Practices for Medical Device Development. https://lnkd.in/e5xmYRx4

Guidance: Software and artificial intelligence (AI) as a medical device https://lnkd.in/gRQz-mdd Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

No "Copy & Paste"! Microsoft's Dragon Medical One, powered by cutting-edge AI technology, allows healthcare professionals to dictate patient notes and medical records directly into ELIXIR, eliminating the need for manual data entry and enhancing overall workflow productivity. Dragon Medical One is compatible with all major EMRs and approved by Te Whatu Ora. #Dragon #Elixir #Dragonmedical #clinicaldocumentation #clinicalnotes #patientmanagement #EMR

As #AI #technology evolves, it’s reshaping the #medicaldevice industry📈 The FDA’s new Predetermined Change Control Plan (PCCP) is a key development for AI-enabled medical device software. In Bold Insight latest blog, Kyle Mullen, PhD explores the PCCP’s key components and offers practical tips for navigating this guidance. https://lnkd.in/gK4npGnn #healthcare #healthtech #GIANT2024

{ T-Pro MirAI: Setting the Standard in Medical Speech Recognition 🎙️ } In healthcare, accuracy isn’t optional—it’s critical. While some providers rely on models like Whisper, which have been shown to produce significant transcription errors and hallucinations, T-Pro is committed to delivering best-in-class performance with our proprietary MirAI models. Recent analyses have revealed the limitations of leading ASR models: - A machine learning engineer found hallucinations in nearly 50% of over 100 hours of Whisper transcriptions. - Another developer identified errors in almost every one of the 26,000 transcripts generated by Whisper. Read the studies here by Fortune and Slashdot: - https://lnkd.in/eW3STEEB - https://lnkd.in/eBSMDzCg At T-Pro, we’ve built our own speech recognition technology, engineered specifically for healthcare, to ensure: ✔️ Precision and reliability for medical terminology ✔️ Tailored solutions that meet the unique demands of clinical environments ✔️ Trustworthy results that clinicians and organisations can depend on When it comes to healthcare, trust matters. That’s why we don’t compromise—we deliver accuracy you can count on. Learn more about MirAI and our industry-leading ASR technology: https://lnkd.in/eiWRkpZt #HealthcareInnovation #AIInHealthcare #ClinicianSupport #Speechrecognition #nhs #mirai #asr

Introducing SmartComplaints™: toward the Future of Medical Device Complaint Coding Exciting news! Today, our sister company Global Exponential Technologies (GxT) is launching the trial version of SmartComplaints™, a software application applying Artificial Intelligence (AI) and Machine Learning (ML) technology to the process of coding complaints for medical devices following the International Medical Device Regulators Forum (IMDRF) coding system.   As highlighted in the MDCG 2022-21 guidance on PSURs, regulatory bodies recommend using IMDRF Adverse Event Terminology to present complaints data. SmartComplaints™ takes raw complaint descriptions and maps them to the standardized IMDRF codes. The result? Consistency, time savings, and enhanced regulatory compliance for better insights to drive patient safety and product improvement. Begin your transition to IMDRF Adverse Event Reporting today and try SmartComplaints™ for yourself!  Click the link to access our free interactive demo and see the application in action! https://lnkd.in/gFf_2rAp Join the conversation and share your thoughts on the importance of standardized complaint coding for medical devices. We'd love to hear from you!   #SmartComplaints #IMDRF #ML #MachineLearning #AI #ArtificialIntelligence #EUMDR #ComplaintCoding #RegulatoryCompliance #QualityImprovement #Innovation #LaunchDay

Exploring AI SaMD Design Traceability Yujan Shrestha, MD and J. David Giese tackle a key question about AI SaMD design controls: Should manufacturers separate their design traceability matrix into product-specific software and technical requirements, and process and regulatory requirements? Or is it more common to see a mix of quantitative and qualitative DTMs? This short video delves into how manufacturers approach traceability for better compliance and design outcomes. 💬 How do you structure traceability for complex AI medical devices? Share your perspective in the comments! #AISaMD #MedicalDevices #DesignControls #SoftwareTraceability #AIinHealthcare #RegulatoryCompliance #HealthcareInnovation #MedicalDeviceDesign #DigitalHealth

Avicenna.AI secures EU-MDR certification for five AI tools Avicenna.AI’s tools, which use AI to screen severe conditions from medical images, have been certified as Class IIb medical devices. The post Avicenna.AI secures EU-MDR certification for five AI tools appeared first on Medical Device Network.... https://lnkd.in/eNWvd8Zk #BioTech #science

No "Copy & Paste"! Microsoft's Dragon Medical One, powered by cutting-edge AI technology, allows healthcare professionals to dictate patient notes and medical records directly into ELIXIR, eliminating the need for manual data entry and enhancing overall workflow productivity. Dragon Medical One is compatible with all major EMRs and approved by Te Whatu Ora. #Dragon #Elixir #Dragonmedical #clinicaldocumentation #clinicalnotes #patientreport #praticemanagement

Chil Femtech Center introduces KETI 4.0, an AI Companion designed to assist in comprehending medical records. This groundbreaking tool enables users to input medical text, receiving simplified explanations in their preferred language. KETI does not substitute professional medical advice; it serves as a supplementary resource. Expert guidance remains paramount. https://lnkd.in/dKvTTDCD