FDA approves Artificial Intelligence Software for Identifying Brain Bleeds

FDA approves Artificial Intelligence Software for Identifying Brain Bleeds

According to a recent report, Food and Drug Administration (FDA) has given approval for the software developed by MaxQ AI. The software is an Artificial Intelligence-based solution to diagnose and determine non-contrast CT examination images which is known as brain bleeds. Accipio Ix Intracranial Hemorrhage (ICH) of MaxQ AI uses the artificial intelligence technology platform to analyze head CT images automatically. Aidoc says that it is first of its kind in-depth learning solution to benefit radiologists in workflow group. Without affecting the workflow of the physician, this Healthcare AI technology…

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FDA to Update Premarket Guidance for Medical Device Security

FDA to Update Premarket Guidance for Medical Device Security

FDA Commissioner Scott Gottlieb, on 5th September said, “FDA is planning to update its premarket guidance for medical device security.” He further added, “We have made significant progress to improve the cybersecurity of medical devices. But the industry is rapidly evolving with respect to data security and we need to keep up the pace.” This guidance will have recommendations for manufacturers for the protection against moderate and major ricks which are capable of disrupting & exploiting clinical operations through remote attack. He further added that the FDA will share number…

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