Braun Gets FDA Nod for Xevonta Dialyzer September 2, 2016 Braun expects to offer the xevonta filter in September. Read More
Cianna Medical Nabs FDA Clearance for Savi Scout Radar Localization Device August 26, 2016 The device uses infrared light to locate target tissue. Read More
NICE Gives Nod to HeartFlow’s Cardiac Imaging Platform August 26, 2016 The device is intended for patients with onset chest pain of cardiac origin and a risk for coronary artery disease. Read More
FDA Approves Post-Concussion Testing Devices August 25, 2016 The two devices are the first to be indicated for cognitive assessment after a concussion. Read More
Court Consolidates Class Action Suits Against Theranos August 25, 2016 A federal judge combined six class actions that allege fraud and false advertising. Read More
Oculus Secures FDA Clearance for Post-Dermal Device August 24, 2016 The device is designed to remove foreign material and debris after dermal procedures. Read More
Amedica Earns FDA Clearance for Expanded Sizes of Valeo II Lateral Lumbar Device August 24, 2016 The expanded sizes are intended to accommodate a broader range of patient anatomies. Read More
Edwards Transcatheter Heart Valves Approved in Intermediate-Risk Patients August 22, 2016 The FDA lowers the risk level required for use of the heart valves. Read More
FDA Grants Approval for Expanded Indication for 2 Transcatheter Heart Valves August 19, 2016 FDA is requiring manufacturers to monitor patients in clinical studies for 10 years. Read More
Alere Receives FDA Clearance for Alere I RSV Rapid Molecular Test August 19, 2016 The device delivers results in 13 minutes or less. Read More
FDA Simplifies Tips for Electrosurgical Device, Vessel Sealer Submissions August 19, 2016 FDA is advising sponsors to rely on an original 510(k) as a reference. Read More
Chinese FDA Awards MammaTyper Innovative Product Status for Expedited Approval August 19, 2016 Only ten in vitro diagnostics devices have been granted access to the special approval process. Read More