Multiplex #IVD devices | Assessment Common Approach
IVD news August 23, 2022Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with... read more
Draft of Principles and Practices for Software Bill of Material for Medical Device Cybersecurity
SOFTWARE news August 23, 2022Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from... read more
IMDRF Machine Learning-enabled Medical Devices: Key Terms and Definitions
SOFTWARE news June 3, 2022The main purpose of this new guidance t is to create uniform expectations and understanding for Machine Learning-enabled Medical Devices... read more
Companion Diagnostic in Precision Medicine
IVD news 27 November, 202165% of EMA and FDA drug approvals involved a biomarker between 2015 and 2019. Currently, 44 CDx are approved by the FDA, and the most relevant categories in terms of the number of approvals are NSCLC and colorectal cancer.
AI and the Software as a Medical Device
SOFTWARE news 27 November, 2021Deep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.
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