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Minneapolis, Minn.-based Greatbatch has issued a field corrective action for its Standard Offset Cup Impactor, after a sterility level of 10-6 was not achieved when the device was subjected to steam sterilization cycles during a recent design and manufacturing transfer, company spokesman Christopher Knospe told Device Daily Bulletin. Read More
The FDA could sign off on STAAR Surgical’s Visian Toric Implantable Collamer Lens within the next several months, following an advisory panel’s conclusion that the lens is approvable. Read More
NeoMedix wound up in the crosshairs of FDA investigators for online claims that its Trabectome tissue removal device is effective in treating glaucoma. Read More