All posts tagged "510k"
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56Health NewsRespiratory Health company AireHealth lands 510(k) for connected nebulizer
AireHealth, a Floridian startup focused on the respiratory health space, landed an FDA 510(k) clearance for its connected nebulizer VitalMed. The device...
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33Health NewsEtiometry adds more clinical decision support tools to its platform with 510(k) clearance
Etiometry has received 510(k) clearance from the U.S. Food and Drug Administration to add enhancements to its clinical decision support platform for...
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91Health NewsAncestry’s new 510(k) clearances point toward OTC consumer genetic health risk testing
Consumer genomics company Ancestry recently received two FDA 510(k)s – one for an in vitro molecular test that detects genomic variants tied to potential...
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97Health NewsZebra Medical Vision receives 510(k) clearance for AI mammogram tool
Zebra Medical Vision has announced its latest Food and Drug Administration 510(k) clearance for HealthMammo, an artificial intelligence tool that helps radiologists...
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96Health NewsVitls scores 510(k) clearance for continual and remote vital signs monitoring device
Today the remote and continuous monitoring platform Vitls announced that it has received 510(k) clearance from the FDA. The Vitls Platform uses...
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126Health 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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70Health 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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110Health 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...
