FDA Issues Warning Letter to C.R. Bard Over Quality Systems, Unapproved Devices August 28, 2015 The FDA has come down on C.R. Bard for not addressing quality systems and medical device reporting observations at two of its plants. Read More
Edwards Acquires CardiAQ for Up to $400 Million August 27, 2015 Edwards will use CardiAQ’s TMV implant to advance therapy for patients with mitral valve disease. Read More
Teleflex Recalls Endobronchial Tube Due to Faulty Connector August 27, 2015 Customers complained that the tube’s double swivel connector was breaking or separating on the tube. Read More
Hospira, Cerner Reach New Agreement to Advance IV-EMR Technology August 27, 2015 The agreement enhances interoperability between Hospira's smart IV infusion devices and Cerner's CareAware solutions. Read More
Rivanna Begins Manufacturing of Accuro Device August 27, 2015 The device is designed to guide spinal anesthesia with automated 3D navigation technology. Read More
ECM Acquires Rights to Distribute Vertebral’s Interfuse System in Greater China August 27, 2015 The implant enables spinal surgeons to achieve an anterior lumbar interbody fusion footprint with familiar, less-invasive approaches. Read More
Roche Inks Asset Purchase Agreement with Lumora August 26, 2015 The deal is for products associated with the patent-protected Heat Elution nucleic acid purification technology. Read More
Burning Rock, Illumina to Co-Develop Molecular Diagnostics for Oncology August 26, 2015 The companies want to develop a user-friendly, oncology molecular diagnostic kit for the Chinese market. Read More
Veritas Receives CE Mark Approval for Hereditary Breast and Ovarian Cancer Screening Test August 26, 2015 The test sequences the BRCA1 and BRCA2 genes using proprietary gene-targeting technology. Read More
Medtronic Acquires Twelve for $458 Million August 26, 2015 Twelve’s transcatheter mitral valve replacement device is designed to treat mitral valve regurgitation in patients. Read More
HealthMyne Secures 510(k) Clearance from FDA for Imaging Informatics Platform August 26, 2015 The tools can increase radiologist efficiency by automating both data capture and structured report. Read More
Agena Bioscience Introduces Chip Prep Module August 25, 2015 Module enables laboratories to operate MassARRAY 96-well System largely unattended for high-throughput, multiplex genetic analysis. Read More