Luminex Strep Assay Wins FDA Clearance November 3, 2017 This is the sixth assay to receive the FDA’s clearance for use in the ARIES system. Read More
FDA Clears Atlas Spine’s Expandable Implant November 3, 2017 Surgeons can pack graft material after the device is deployed. Read More
FDA Clears Ultrasound and Electric Field Simulation Device November 2, 2017 The device includes software that provides an integrated patient and wound management system. Read More
Abbott Secures FDA Clearance for Diagnostic Systems November 2, 2017 The separate systems for clinical chemistry testing and immunoassay testing can be used individually or as a unit. Read More
IRadimed Receives FDA 510(k) Clearance of MRI Compatible Patient Vital Signs Monitor November 1, 2017 The device has a wireless tablet remote control that allows for the effective communication of vital signs to clinicians. Read More
Abbott Receives CE Mark for XIENCE Sierra Stent November 1, 2017 Abbott submitted an application to the FDA for XIENCE Sierra approval. Read More
Butterfly Network Receives 510(K) Clearance for Chip-Based Imaging System October 31, 2017 The company develops artificial intelligence applications. Read More
Alcyone Wins CE Mark for Alivio Ventricular Catheter and Flusher System October 31, 2017 The system is designed to unblock ventricular catheters. Read More
Nitiloop Wins FDA 510(k) Clearance for Microcatheters October 30, 2017 The company produces cardiovascular and peripheral microcatheters for complex lesions. Read More
Medacta Receives FDA Clearance for Anatomic and Reverse Shoulder Systems October 30, 2017 The Shoulder System is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute’s Clinical Excellence. Read More
Acutus Medical Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias October 27, 2017 The system combines ultrasound anatomy construction with the ability to map the electrical-conduction of each heartbeat. Read More
Ortek Therapeutics Receives FDA Clearance for Cavity Detection Device October 27, 2017 Tooth enamel is electrically non-conductive unless breached by fracture or demineralization. Read More