FDA Dings X-Zeal on Design Validation, Reporting Procedures February 16, 2017 The user manual did not ensure that installation instructions were validated by dentists. Read More
Risk Rankings Can Help Manage Suppliers, Expert Says February 16, 2017 Device manufacturers should explore the use of additional risk factors to supplement traditional quality metrics. Read More
FDA Awards Marketing Clearance to Centric Medical’s Metatarsal Hemi Implant System February 15, 2017 The device is a single use implant intended to be used with or without bone cement. Read More
FDA Grants Marketing Clearance to Cepheid’s Xpert Xpress Flu And Xpert Xpress Flu/RSV February 15, 2017 The built-in redundancy results reduce the impact of seasonal genomic drift in flu viruses. Read More
FlowAid Gets FDA Market Clearance for the FA100 SCCD February 15, 2017 The device increases local blood circulation. Read More
Masimo Gains CE Mark for Respiration Rate Measurement Device February 15, 2017 The device does is not available in the U.S. Read More
Medtronic Earns FDA Clearance, CE Mark for Catheter Products February 14, 2017 The diagnostic products are now available in the U.S. and Europe. Read More
Advisory Group Recommends Adding UDIs on Claims Forms February 14, 2017 Industry groups oppose the recommendation as an unnecessary regulatory burden that could cause more problems than it solves. Read More
Savaria Concord Lifts Cited for CAPA Procedures February 14, 2017 Savaria Concord Lifts makes wheelchair lifts, stair lifts, home elevators, and related devices. Read More
Republicans Plan to Tackle FDA User Fee Reauthorization by June February 14, 2017 Work on FDA user fees will follow a similar timeline to the last user fee agreement, which was signed in June 2012. Read More
Access Scientific Gains FDA Clearance for Powerwand February 13, 2017 The device is made of ChronoflexC and is longer than standard hospital IVs. Read More
FDA Grants Approval to Alesi Surgical’s Ultravision System February 13, 2017 The device improves visibility of surgeons during use. Read More