LaserSight seeks hyperopia indication for laser:
This article was originally published in Clinica
LaserSight has filed a PMA supplement application to the US FDA for marketing approval to use its LaserScan LSX excimer laser system for performing LASIK treatments of hyperopia and hyperopic astigmatism. The Winter Park, Florida company filed a PMA supplement to use the laser in LASIK treatments of myopia and myopic astigmatism last year.
You may also be interested in...
A randomized COVID-19 study spanning the whole of the UK could help to bolster the UK’s reputation as a location for future clinical trials. It is also being seen partly as the result of the UK regulator's "decisive action" in fast-tracking trials for potential COVID-19 therapies.
Manufacturers of endoscopic equipment, biofeedback devices and thermometers were among those cited for regulatory violations in US FDA warning letters this week. A total of four device-related enforcement missives were released by the agency.
The biopharma industry has struggled to recruit patients into clinical trials that adequately reflect the diverse patient populations they hope to reach with new products. Failure to improve minority subgroup participation now will cost trial sponsors later.