Synopsys Launches 3D Imaging Tool After Gaining CE Mark February 12, 2019 The tool can be used for simulating and evaluating a patient’s surgical treatment options. Read More
FDA Approves Grifols’ Babesia Test February 11, 2019 Babesia is a malaria-like parasite that can be spread through blood from infected donors. Read More
FDA Exempts Certain Unclassified Devices From Premarket Notification February 8, 2019 Products exempt from premarket notification requirements include fertility diagnostics and a spine curvature device. Read More
VentureMed Group Appoints New CEO February 8, 2019 Paulson previously served as Restore Medical’s president and CEO, where he guided Medtronic’s 2008 acquisition. Read More
Orchestrate Orthodontics’ 3D Printing Software Cleared for Marketing February 8, 2019 The software system allows dentists to design and produce their own orthodontic clear aligner appliances. Read More
Altona Gains CE-IVD Mark for Hep C Diagnostic Kit February 8, 2019 The test is for use with the devicemaker’s AltoStar automation system. Read More
FDA Clears Wearable Patient Monitoring Device February 7, 2019 The monitor measures a patient’s vital signs up to every two seconds. Read More
OrthoFix’s Cervical Disk Approved February 7, 2019 The device imitates the structure of a natural disc and provides shock absorption. Read More
Teleflex Gains Premarket Approval for Vascular Closure Device February 6, 2019 A clinical trial of the device successfully hit all primary and secondary endpoints. Read More
FDA Approves Cook Medical’s Dissection Endovascular Device February 6, 2019 The Zenith system is less invasive than open surgery. Read More
FDA Clears Zimmer Biomet’s Robotic Knee Platform February 5, 2019 The device uses a proprietary imaging protocol that generates preoperative images. Read More
Oxipit’s Chest X-Ray Analysis Tool Gets CE Mark February 5, 2019 The tool locates similar chest x-rays in a database and then provides an analysis and preliminary report findings. Read More