Tags : 510(k) Clearance

Boston Scientific Receives the US FDA’s 510(k) Clearance for its

Shots: LUX-DxICM System is a dual-stage algorithm diagnostic device implanted in patients to identify AF, atrial flutter, rhythm pause, bradycardia, and tachycardia episodes and detect arrhythmias when established thresholds or parameters are exceeded The dual-stage algorithm verifies arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Additionally, after implant, […]Read More

Zimber Biomet’s Rosa Knee System Receives the US FDA’s 510(k)

Shots: Rose Knee System is a 3D tool designed for the improvement in performing knee replacement surgery to facilitate implant positioning of soft-tissues  during surgical procedures The device is based on Zimber’s X-Atlas imaging portfolio allowing the use of computers for controlling the surgical movements in real-time and creating a 3D model of patient’s anatomy […]Read More