Koning Gets FDA Green Light for 3D Breast Imaging System February 5, 2015 The system images the entire breast with a single scan and provides increased patient comfort. Read More
Medtronic’s Melody Transcatheter Pulmonary Valve Wins FDA Nod February 4, 2015 Previously available via a humanitarian device exemption, the device but showed safety and efficacy in new studies. Read More
FDA Approves First Tissue Adhesive for Internal Use February 4, 2015 TissuGlu is used to connect abdominal tissue flaps. Read More
MedShape Gets FDA Nod for 3D-Printed Bunion Correction System February 3, 2015 The FastForward Bone Tether Plate is part of the FastForward Bunion Correction System. Read More
FDA Gives Green Light to ev3’s Protégé GPS Self-Expanding Stent System February 2, 2015 The stent is for opening leg arteries that have narrowed due to formation of plaque. Read More
Medtronic Gets CE Mark for Larger Expanding Valves February 2, 2015 The CoreValve Evolut R System is now available in three sizes: 23 mm, 26 mm and 29 mm. Read More
Blue Belt Earns CE Mark for Stride Knee System January 29, 2015 The system has been available in the U.S. since October. Read More
FDA Rejects Venaxis 510(k) for APPY1 Blood Test January 29, 2015 The test helps to identify children and young adults who are at low risk for appendicitis. Read More
Agilent’ Microarray Scanner Approved in China for In Vitro Diagnostics January 28, 2015 The system measures and compares DNA and RNA targets. Read More
FDA Approves PARI’s eRapid Nebulizer System for Cystic Fibrosis Drug Delivery January 28, 2015 The nebulizer can deliver Genetech’s Pulmozyme faster than conventional nebulizers. Read More
FDA Gives Nod to New Flexible Ablation Catheter from St. Jude January 28, 2015 The flexible catheter tip was designed to better conform to cardiac anatomy. Read More
AliveCor’s Atrial Fibrillation-Detecting Algorithm Gets CE Mark January 27, 2015 The algorithm, available via an app, will be marketed in the UK and Ireland. Read More