Minimally Invasive Glaucoma Device Guidance Finalized
This article was originally published in The Gray Sheet
Executive Summary
The "leap frog guidance” outlines clinical and non-clinical testing recommendations for the nascent field of minimally invasive glaucoma surgical (MIGS) devices. It closely matches a February draft guidance.
You may also be interested in...
Newly Public Glaukos Unveils Vision For The MIGS Market
Glaukos held its first earnings call Aug. 12 following the completion of its $113 million IPO, which closed in June. The firm is the first to the U.S. market with a micro-invasive glaucoma surgery, or MIGS, device and it is working to get its next-generation system that can be performed separate from cataract surgery to market in the coming years.
FDA Leaps To Draft Glaucoma Device Guidance
FDA issued a "leap frog" draft guidance for minimally invasive glaucoma surgery (MIGS) devices based on strong interest in the nascent field from manufacturers. The recommendations under the guidance reflect discussion during a 2014 stakeholder workshop.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.