Ortho Clinical Diagnostics Earns CE Mark Approval June 21, 2016 The new addition expands the company’s existing infectious disease portfolio. Read More
Lombard Medical Gains CE Mark Approval June 21, 2016 The company expects a full launch later in the year. Read More
SpineGuard Scoops Up FDA Clearance for PediGuard June 17, 2016 The device can be used in open or minimally invasive procedures for pedicle screw insertion. Read More
REBIScan Earns FDA Clearance for Pediatric Vision Scanner June 17, 2016 The device is designed for the early detection of amblyopia and strabismus in young children. Read More
LifeTech Scores CE Mark for LAA Closure System June 16, 2016 The device is intended to close the left atrial appendage percutaneously via a small 8-10 Fr sheath. Read More
BlueWind Medical Earns CE Mark for Overactive Bladder Neurostimulator June 15, 2016 Patients can wear the device for only 30 minutes. Read More
Protagen AG Gains CE Mark for Systemic Sclerosis Test June 15, 2016 The test uses the company’s SeroTag technology platform. Read More
Meridian Bioscience’s Illumigene Mycoplasma Test Nabs FDA Clearance June 15, 2016 The test uses throat swabs to detect infection on the first day of symptoms. Read More
Vela Diagnostics Earns CE Mark for Sentosa Assay June 14, 2016 The test is intended for in vitro diagnostic purposes. Read More
FDA Greenlights Hologic and Grifols’ Zika Virus Assay June 13, 2016 The test is intended to screen donated blood for the Zika virus. Read More
SI-BONE Earns FDA Clearance for Changes to iFuse System June 13, 2016 The device was originally cleared in November 2008. Read More
Masimo Gains FDA Clearance for O3 Regional Oximetry June 13, 2016 The device is designed to continuously monitor cerebral oxygen saturation. Read More