01/24/2011 Reprinted with permission from www.fdaweb.com As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure. Adding to data in a petition for […]
FDAer Who OK’d LASIK Petitions for Revocation
Reprinted with permission from www.fdaweb.com 01/06/2011 Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who has publicly said the agency “screwed up” when it approved LASIK vision enhancement lasers on his watch in 1997, petitioned the agency 1/6 to undo that mistake by “withdraw[ing] FDA approval (PMA) for all LASIK devices and […]