Visx meeting with FDA to discuss Star PRK laser's high myopia, astigmatism capacities.
This article was originally published in The Gray Sheet
Executive SummaryVISX 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...
A collaboration between Novo and Fauna will look at animal hibernation and genetic sequencing for hints toward novel therapies for obesity. Pfizer will use Insilico’s machine learning technology in target validation.
The introduction of gene therapies has been the highest-profile new modality to reach the market, but new RNA-based therapeutics hold significant potential and could be more accessible for patients. Scrip reviews the leading drug developers in this space.