In Brief: Summit Technology
This article was originally published in The Gray Sheet
Executive Summary
Summit Technology: Premarket approval application supplement for use of the company's Apex Plus excimer laser system in correcting myopic astigmatism was submitted to FDA on April 2, the company says in an April 25 release. Summit received FDA approval in February to market the Apex Plus system in the U.S. for photorefractive keratectomy and phototherapeutic keratectomy, the same indications as the SVS Apex system ("The Gray Sheet" Feb. 24, In Brief). The Plus system incorporates software and hardware modifications that allow use of an erodible laser disk to perform astigmatism correction...
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.