Tag: FDA 510(K)
Nuvo Group’s Remote Uterine Activity Monitoring Module Gets 510(k) FDA Clearance
Remote pregnancy monitoring company Nuvo Group announced that it has received FDA clearance to add a new uterine activity module that provides capability for...
Natural Cycles Submits Premarket Notification to the FDA for Wearable Birth Control
Natural Cycles, which claims to be the first and only FDA-cleared birth control app in the United States and CE-marked birth control app in...
Vitls Wins FDA Clearance For Its Remote Patient Monitoring Platform
Houston, Texas-based Vitls Inc. won FDA 510(k) clearance for its Vitls Platform. The Vitls Platform is a combination of a vitals monitoring patch, cloud...
Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx Implantable Cardiac Monitor System
Boston Scientific has received FDA 510(k) clearance for its LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term implantable diagnostic device to detect arrhythmias...
Headsafe Earns FDA Clearance For Its Brain Assessing Headset
Sydney, Australia-based brain health technology company Headsafe received FDA 510(K) clearance for its Nurochek brain-function assessment system. This news means the company will be...