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Navilyst Medical, a subsidiary of AngioDynamics, received an FDA warning letter for quality issues at two facilities, including the sale of sterile product that contained foreign matter such as hair. Read More
The agency cleared the company’s ReSolve biliary locking drainage catheter, the ONE Snare endovascular microsnare system and the AEROmini tracheobronchial stent system. Read More
The Senate late Saturday approved a spending bill that gives the FDA just over $420 million in medical device and diagnostics regulatory funding, a slight drop from current levels. Read More
Inadequate CAPA procedures led all other causes for Form 483s issued to devicemakers in fiscal 2014, while purchasing control issues jumped from sixth place to third in the FDA’s annual ranking of inspection observations. Read More
A Government Accounting Office review of Medicare’s competitive bidding program shows that payment amounts for a sample of 28 Healthcare Common Procedure Coding System codes generally decreased during all bidding rounds, compared with the average fee-for-service payment for the same codes in 2010. Read More