AMO approval
This article was originally published in The Gray Sheet
Executive Summary
FDA approves Advanced Medical Optics' PMA for CustomVue Monovision LASIK, the first system to allow laser treatment of one eye for distance vision and the other eye for close-up vision, the agency announces July 12. AMO acquired the device through its 2005 purchase of VISX. The company needs to conduct a 500-patient post-approval study assessing patients six months following surgery for visual disturbances...
You may also be interested in...
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.