SUMMIT'S OMNIMED EXCIMER LASER APPROVABLE CONTINGENT ON SUBMISSION OF ADDITIONAL DATA, PANEL RECOMMENDS; COMPANY EXPECTS APPROVAL BY END OF 1995
This article was originally published in The Gray Sheet
Executive Summary
Summit Technology's OmniMed excimer laser should be approved by FDA for treating nearsightedness with photorefractive keratectomy as long as the company can meet a number of additional requirements, the agency's Ophthalmic Devices Panel recommended in a 13-1 vote at an Oct. 20 meeting in Gaithersburg, Maryland.
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.