Qiagen NSCLC Companion Diagnostic Lands PMA Approval July 16, 2015 The therascreen EGFR test for non-small cell lung cancer identifies candidates for AZ’s Iressa treatment. Read More
Luminex Submits FDA 510(k) Application for Aries Products July 15, 2015 The application is for a molecular diagnostics platform and a herpes simplex virus 1&2 assay. Read More
Rivanna’s Accuro Device Secures Expanded Indication July 13, 2015 The product can now be used for three-dimensional imaging of the abdominal, musculoskeletal, cardiac and peripheral vascular anatomies. Read More
Thoratec Snags CE Mark Approval for HeartMate PHP July 13, 2015 The device features a catheter that can generate an average blood flow of four to five liters per minute, company claims. Read More
Cardiovascular Systems Snags FDA Clearance for ViperWire July 8, 2015 The device is meant for use with the company’s peripheral orbital atherectomy systems. Read More
Cynosure’s SculpSure Snags Expanded Indication July 7, 2015 The treatment can be used for lipolysis of the abdomen. Read More
Vygon to Buy Perouse Medical July 7, 2015 Vygon will gain access to the French devicemaker’s 162 patents. Read More
Theranos Wins FDA Nod for Herpes Finger Stick Test July 6, 2015 This is the company’s first clearance. Read More
Alcon Gains CE Mark for Intraocular Lens Delivery System July 2, 2015 The system combines a manually loaded device with a disposable, pre-loaded injector, company claims. Read More
BioLight’s Bladder Cancer Test Secures CE Mark July 1, 2015 In a clinical trial, the product displayed sensitivity rates of 84.4 percent and specificity rates of 82.7 percent, company claims. Read More
Velano Vascular Gains CE Mark for Blood Draw Technology June 30, 2015 The device uses a peripheral intravenous catheter to gather blood specimens. Read More
Centinel Spine’s Stalif Line Wins Expanded Indication June 30, 2015 The products can be used for multilevel, cervical spine fusion procedures. Read More