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

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

More lungs will be available for transplant in the U.S. if a device recommended by an FDA advisory panel gets a green light for broader use. Read More

New FDA draft guidance on blood glucose test systems, released in January, shouldn’t lengthen approval times, a CDRH official assured devicemakers Wednesday during a webinar hosted by the American Association for Clinical Chemistry. Read More