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
Magellan Diagnostics Distributed Unapproved Testing Systems, FDA Says October 27, 2017 Magellan, a subsidiary of Meridian Bioscience, received a Form 483 after an FDA inspection revealed significant violations. Read More
FDA Clarifies When New 510(k)s Are Required for Device Updates October 27, 2017 The agency issued separate guidance for software. Read More
Medineering Wins CE Mark for Its Positioning Arm October 26, 2017 The technology is designed to assist surgeons in complex anatomical areas. Read More
Renishaw Wins FDA Approval for Neurosurgery Planning Software October 26, 2017 Neurosurgeons can use the software to create plans based on procedure type. Read More
Abbott Wins Marketing Clearance for First Smartphone-Compatible Cardiac Monitor October 25, 2017 The data collected are transmitted to a physician via a mobile app. Read More
FDA Approves New Nebulizer for Tyvaso Inhalation System October 25, 2017 Tyvaso was originally approved by the FDA for the treatment of pulmonary arterial hypertension in 2009. Read More