Food & Drug Administration (FDA)
Weight loss: FDA approves EnteroMedics Maestro obesity device
A ventilator Covidien’s Nellcor arm attracts another Class I recall | Regulatory news for the week of January 12, 2015
Diabetes: Tandem ticks up on FDA nod for t:flex insulin pump
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."