Visx meeting with FDA to discuss Star PRK laser's high myopia, astigmatism capacities.
This article was originally published in The Gray Sheet
VISX STAR PRK LASER SOFTWARE WITH HIGH MYOPIA, ASTIGMATISM CAPABILITY was part of the Star photorefractive keratectomy laser system approved by FDA March 27 although the agency did not approve the two indications, Visx maintains. Visx' statement responds to Summit allegations, spelled out in a June 24 letter to FDA, that by providing software capable of treating high myopia and astigmatism, Visx is "intentionally distributing unapproved devices."
You may also be interested in...
The three names under consideration also have a history of focusing on helping underprivileged communities get access to health care.
With operations in the MENA region already tracking to $700m in revenues for 2020, Hikma is looking to grow the business further after beginning negotiations with GSK to buy certain of the originator’s businesses in Egypt and Tunisia.
A safety study of Pfizer's anchor immunology brand Xeljanz showed higher rates of heart attacks and cancer versus a TNF inhibitor.