AireHealth, a Floridian startup focused on the respiratory health space, landed an FDA 510(k) clearance for its connected nebulizer VitalMed. The device...
Etiometry has received 510(k) clearance from the U.S. Food and Drug Administration to add enhancements to its clinical decision support platform for...
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...
Zebra Medical Vision has announced its latest Food and Drug Administration 510(k) clearance for HealthMammo, an artificial intelligence tool that helps radiologists...
Today the remote and continuous monitoring platform Vitls announced that it has received 510(k) clearance from the FDA. The Vitls Platform uses...
London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to...
This morning the FDA granted Australian company Headsafe a 510(k) clearance for its connected headgear that is able to perform an assessment...
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to...