French device manufacturer Biom’Up announced it secured FDA marketing approval for its Hemoblast Bellows device seven months ahead of schedule.
The device is a best-in-class hemostatic product used to control bleeding during surgery. The FDA based the approval on a 412-patient clinical trial that met all clinical endpoints with high statistical significance.
The approval followed an FDA inspection of the facility where the device is manufactured, during which the agency found no deficiencies. The company plans to market the device in the United States by next summer.