Food & Drug Administration (FDA)
BD, CFN settle merger lawsuits | Medtech legal news for the week of January 12, 2015
BD gains on Intelliport clearance from FDA
FDA lifts import ban on Hospira infusion pumps
SynCardia wins FDA nod for destination therapy trial
SynCardia plans to test its artificial heart as a permanent implant rather than a placeholder for donor transplants in 19 patients. The Arizona company said it won the FDA’s approval to move ahead with the clinical study of its temporary Total Artificial Heart as a permanent transplant option. This is a big advance forward for […]
Cohera Medical wins approvable letter from FDA for TissuGlu surgical sealant
Cohera Medical today said it received an "approvable letter" from the FDA for its TissuGlu surgical sealant, noting that it expects to win pre-market approval "within a few weeks."
Ebola: FDA OKs investigational study for Aethlon blood filter
FDA approves Medtronic’s In.Pact Admiral balloon
Another important step in FDA’s journey towards enhanced safety through full-scale “active surveillance”
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.