Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

In Brief: Visx' Star

This article was originally published in The Gray Sheet

Executive Summary

Visx' Star: Excimer laser is approved via PMA supplement for treatment of moderate-to-severe myopia between -6 and -12 diopters with up to -4 diopters of concomitant myopic astigmatism, the firm reports Jan. 29. The system was previously approved for myopia up to -6 diopters with myopic astigmatism of up to -4 diopters. "Greater than 99% of nearsighted consumers, with or without astigmatism, are now eligible for laser vision correction" with the device, the firm claims. The firm plans to file for approval of hyperopia treatment in the first quarter...

You may also be interested in...



Journey East: How Chinese Returnees Build Global-Bound Biopharmas

As Chinese returnees transform their startups to fully-fledged biopharma operations with a full product lineup and the global market in sight, the journey has been filled with challenges. Based on interviews and on-the-ground reporting, this new series takes a closer look at several companies' experiences.

US FDA Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., CBER’s Marks Says

Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.

COVID-19 Vaccines: AstraZeneca’s UK Study Not Good Enough For US FDA Authorization, Slaoui Says

Operation Warp Speed chief scientific advisor confirms doubts about the Phase III data from two UK and Brazil studies; says efficacy results in US trials of AstraZeneca and Janssen vaccines expected by mid-January.

UsernamePublicRestriction

Register

OM013133

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel