All posts tagged "510k"
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43Health NewsCircadia Health’s contactless respiration rate monitor receives 510(k) clearance
London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to...
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9Health NewsHeadsafe lands FDA 510(k) for its connected brain checkup device
This morning the FDA granted Australian company Headsafe a 510(k) clearance for its connected headgear that is able to perform an assessment...
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15Health NewsFDA: Devs can release digital products for psychiatric disorders without 510(k) submission during COVID-19 crisis
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to...
