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Examples of SaMD include software that makes a diagnosis using patient information, X-ray image processing software and smart phone apps that calculate a patient’s required insulin doses using their blood glucose levels. Read More
Many of the inspection findings were repeat observations, flagging document control procedures, labeling activities, and measuring and test equipment not suitable for the intended purpose. Read More
Garmin notes that the use of wearables as health and medical tools is rapidly evolving and the company is “committed to the development of wearables that can lead to the detection of serious health conditions.” Read More
The firm’s quality director and a lab analyst were “unable to explain what ‘deleted result’ meant and they were unable to provide records or documentation explaining the events,” the 483 said. Read More
The company is developing he system for use in overactive bladder treatment, as well as deep brain stimulation for treating Parkinson’s disease. Read More