Quick blog.
I received a note today from the BRAVA people that states, “The FDA has determined there are no subject protection concerns that preclude initiation of the investigation and has approved BRAVA LLC’s application subject to minor modifications of the informed consent…. We have been given permission to resume the referenced study. ”
Furthermore, the FDA categorized the BRAVA device as CMS Reimbursement Category B1 type, which now allows the device to obtain insurance reimbursement via the Centers for Medicare and Medicaid Services, and presumably by private insurers as well, on a going forward basis, so long as they are participants of the current clinical trials.”
She goes on to state that they are almost fully enrolled in this study. There will by a new and final randomized, controlled, and multi center study to validate the device’s efficacy.