Visx's Laser System gains supplemental PMA
This article was originally published in Clinica
Executive Summary
The STAR S4 IR, an excimer laser system developed by Visx, has gained a supplemental PMA, allowing it to be used in the US to treat myopia - shortsightedness - by removing tissue from the centre of the cornea to flatten it. It can also treat astigmatism by flattening the central cornea by different amounts and at different orientations to correct for uneven focus. It is approved to treat patients over 40 years of age with myopic astigmatism, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted eye.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.