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Digital health technology supporting chronic disease management under the FDA’s new TEMPO pilot program.

FDA Introduces TEMPO Pilot to Accelerate Digital Health for Chronic Diseases
Illustration of inductive coupling powering an implantable IoT device through human tissue

Batteryless Power Transfer in Implantable IoT Devices: Efficiency, Specific Absorption Rate Safety, and IEC 62304 Considerations
Medical device workstation in hospital — highlighting cybersecurity and operating system maintenance.

Windows 10 End-of-Support: What Medical Device Manufacturers Must Know
TGA Introduces EU MDR Transition Web Publication Service

TGA Launches EU MDR Transition Web Publication Service: What Manufacturers Need to Know
Accelerated Aging vs Real‐Time Aging for Implantable Devices

Accelerated Aging vs. Real-Time Aging: Predictive Correlation for Implantable Devices
EU Pilot Coordinated Assessment updates

EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
Modeling degradation kinetics of biomedical polymers used in implantable medical devices through hydrolysis, oxidation, and Arrhenius-based modeling

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
FDA updates Pre-RFD guidance with new recommendations for medical device, drug, and biologic classification.

FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
FDA Draft Guidance on QMSR for Premarket Submissions

FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
Notified Bodies Warn Shortage Could Hinder AI Regulation

Notified Bodies Warn Shortage Could Hinder AI Regulation
MHRA CEO Highlights Risk-Proportionate Regulation for AI & Medical Devices

MHRA Plans Risk-Proportionate AI and Medical Device Oversight
MedTech industry experts discussing proposed reforms to MDR and IVDR regulations.

MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
Illustration showing AI technology and FDA evaluation concept for medical devices

FDA Seeks Feedback on Real-World Performance of AI Medical Devices
FDA’s ASCA program helps medical device makers streamline compliance and submissions.

FDA’s ASCA Program: Transforming Medical Device Compliance
AI and regulatory trends shaping the future of inflammation imaging in healthcare

Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights

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