CB Scientific Submitted Latest myCam Cardiac Event Monitor for FDA Clearance
CB Scientific has submitted a 510(k) application to the FDA for its latest myCam Cardiac Event Monitor.
The company said updated features for the ambulatory ECG recorder include reduced power consumption, enhanced lead wire shielding, improved signal quality and materials sourcing options that effectively shrink critical component lead times by more than half.
The device still has its auto-trigger feature enabling automatic recording of asymptomatic events detected by the algorithm for atrial fibrillation, tachycardia, bradycardia and pauses, CB Scientific said.
The company added that it anticipates a response from the FDA on the submission in 90 to 120 days.