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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
The Medical Device Manufacturers Association is urging members of Congress and other stakeholders to address provisions in anti-patent troll legislation that the group says could harm small medtech innovators. Read More
The FDA may withdraw a humanitarian device exemption if it subsequently approves a PMA or clears a 510(k) for the humanitarian-use device or a comparable device with the same indication, a draft Q&A guidance on HDEs explains. Read More