Acufocus (Irvine, California) managed to get across the finish line with a narrow win at a June 6 advisory committee hearing for the Kamra PMA despite losing a vote on device safety. The vote on whether the benefits appeared to outweigh the risks was 4-3 with one abstention, and it appeared the 7-1 effectiveness vote carried the day despite considerable misgivings expressed by a number of panelists during the course of the hearing, concerns that led to a 5-4 vote that the data did not conclusively demonstrate that the device is safe. Read More
