Regulatory Radar Australia Enforces UDI Regulations – New Era for Device Traceability Begins Australia’s Unique Device Identification (UDI) regulations are […]
MedTech Regulatory Insights May 2025 Read More »
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AI vs. Human Judgment: Spectral AI’s DeepView® System Proves Superior in Burn Care A new AI-driven technology is set to
MedTech Regulatory Insights April 2025 Read More »
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EMA INTRODUCES REGULAR SCIENTIFIC ADVICE PROCESS FOR HIGH-RISK MEDICAL DEVICES On January 17, 2025, the European Medicines Agency (EMA) published
MedTech Regulatory Insights March 2025 Read More »
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The FDA has released a draft of new recommendations aimed at improving the performance accuracy of pulse oximeters, particularly across
MedTech Regulatory Insights Feb 2025 Read More »
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On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to
MedTech Regulatory Insights January 2025 Read More »
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