By Janet Woodcock, M.D.
Food & Drug Administration (FDA)
FDA awards priority review status to Cohera Medical’s surgical sealant Sylys | Regulatory news for the week of December 22, 2014
FDA approves Eos Imaging’s 3D orthopedic software
Eos Imaging said the FDA approved its hipEos 3D software for planning hip replacement surgery.
Eos said the software uses patients’ anatomical data to create a functional, weight-bearing 3D image that can help physicians determine what size implant to use and how it should be positioned.
NxStage Medical wins FDA nod for nocturnal home dialysis
Report: FDA grounds plan to test unmanned inspection drones
Cohera’s Sylys sealant wins quick review at FDA
The FDA awarded priority review status to Cohera Medical‘s surgical sealant Sylys because the product addresses a significant unmet medical need.