In Brief: Visx' Star
This article was originally published in The Gray Sheet
Visx' Star: FDA files premarket approval application supplement for use of the excimer laser for treatment of moderate-to-severe myopia between -6 diopters and -12 diopters with up to -4.00 diopters of concomitant myopic astigmatism, the company says. The supplement has been granted expedited review status, Visx notes. The system is currently marketed for treatment of myopia of -1 to -6 diopters with concomitant myopic astigmatism of -0.75 to -0.4 diopters. The laser requires a "simple software change" to be able to treat the patients covered in the new supplement, the firm states. No additional hardware or disposables are required...
You may also be interested in...
BD and BioMedomics have released a new rapid point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19.
A medtech industry group is asking the Trump administration to clarify if small medical device companies that have equity investors qualify for small business loans and forgiveness under the coronavirus relief package.
Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.