Alere Wins FDA Nod for i Strep A Test April 2, 2015 The test is the first of its kind to detect Group A Strepotococcus bacteria in throat swab specimens in eight minutes or less. Read More
FDA Grants Expanded Labeling Claim to On-X Aortic Heart Valve April 2, 2015 Thousands will be able to reduce their blood-thinning medication requirements. Read More
FDA, Biomedical Engineering Society to Hold Joint Conference April 1, 2015 The conference will focus on medical device computational modeling and simulation. Read More
FDA Approves Five New Performance Upgrades for Lensar Laser System April 1, 2015 The system is the first of its kind to include automation and customization at essential steps of refractive cataract surgery. Read More
FDA OKs Clinical Trial of Smaller SynCardia Artificial Heart April 1, 2015 The study could include as many as 30 heart failure patients — mainly women, smaller men and adolescents. Read More
Orthopedic Surgical Planning iPad App Gains FDA Clearance March 31, 2015 The previous version could be accessed only from a workstation or personal computer. Read More
EDP Biotech Forges ColoMarker Global Distribution Partnership March 31, 2015 The early-stage colon cancer blood test will launch this year. Read More
FDA Approves Medtronic’s CoreValve System for Transcatheter Valve-in-Valve Procedures March 31, 2015 The system is the first U.S.-approved transcatheter heart valve for VIV procedures in high- and extreme-risk patients. Read More
Zimmer Unveils Modular External Fixation System March 30, 2015 The XtraFix eliminates steps, saves time and cuts costs in trauma patient surgery. Read More
Artificial Pancreas Pump System Wins UK Approval March 30, 2015 The device, which could protect thousands, prevents extreme hypoglycemic attacks in diabetes sufferers. Read More
FDA Gives Fetal Micro-Pacemaker Humanitarian Exemption March 30, 2015 The device is the first fully implantable pacemaker for prenates with fetal heart block. Read More
Bioness Initiates Pilot Study of StimRouter Device March 27, 2015 The device has been indicated to treat chronic peripheral nerve pain in overactive bladder sufferers. Read More