Alere Snags FDA CLIA Waiver for i Strep A Test July 17, 2015 The designation allows the test to be used in healthcare settings. Read More
Novo Nordisk’s FlexPro PenMate Wins FDA Nod July 17, 2015 The growth hormone-related disorders treatment will be launched in the U.S. later this year. Read More
Magellan Diagnostics’ Blood Lead Testing System Secures FDA Clearance July 17, 2015 The LeadCare Plus is meant for routine testing in children. Read More
FDA Clears Prosthesis for Above-the-Knee Amputations July 17, 2015 The device is indicated for those unable to use conventional socket prosthesis. Read More
St. Jude Medical Wins FDA Nod for Spinal Cord Stimulator July 16, 2015 The product incorporates Apple products and Bluetooth wireless technology. Read More
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