EU Grants CE Mark to Ortho Clinical Diagnostics’ Software January 11, 2017 The software allows other immunohematology analyzers to connect to the hospital’s laboratory information systems. Read More
SonaCare Medical Receives FDA Marketing Clearance for Revised Prostate Tissue Removal Device January 11, 2017 The device includes a tissue change monitoring which quantifies RF signals. Read More
UK Issues Safety Notices for Suction Unit, Blood Analyzer January 11, 2017 Suction units manufactured after May 2015 might not be able to be turned off without removing the power source. Read More
FDA Grants Marketing Clearance to Arterys’s Medical Imaging Analytics Cloud Software January 10, 2017 The software provides automated, editable ventricle segmentations based on conventional cardiac MRI images. Read More
Qiagen Submits Quantiferon-TB Gold Plus for FDA Pre-Market Approval January 10, 2017 This submission follows the 2016 launch in Europe, the Middle East, Africa, Asia and Latin America. Read More
Teleflex Receives Marketing Clearance for its Arrow VPS Rhythm Device January 10, 2017 The device assists in placement and confirmation of a catheter tip in the superior vena-cava-cavoatrial junction. Read More
United Contact Lens Cited for Testing, Complaint Procedures January 10, 2017 The FDA inspected United’s Arlington, Wash., facility in October 2016. Read More
Abionic Secures CE Marks for Sepsis and Iron Deficiency Diagnostics January 9, 2017 The tests provide a diagnosis at the point of care. Read More
Orthofix Earns FDA Approval, CE Mark for Bone Growth Stimulators January 9, 2017 The stimulators activate and boost the body’s healing process. Read More
New Zealand Proposes to List New Hip, Knee Implants January 9, 2017 The proposal would let Stryker New Zealand sell about 3,700 orthopedic joint implants to hospitals. Read More
FDA Strikes Agreements to Use Device Registries January 9, 2017 The agreements are part of the agency’s continued effort to harness real-world evidence. Read More
FDA Awards 510(K) Clearance to ivWATCH for Continuous Monitor January 6, 2017 The monitor detects IV fluid leaks outside the vein into surrounding tissue. Read More