Biom’Up receives FDA marketing approval for HEMOBLAST™ Bellows, its flagship product
Saint-Priest, France, December 18, 2017 – Biom’Up, specialist in surgical hemostasis, announces today that it has received FDA marketing approval for HEMOBLASTTM Bellows, its flagship product, 7 months ahead of schedule.
This pre-marketing approval (PMA), which allows a Class III medical device to be marketed in the United States, is the most stringent pathway to approval by FDA for devices. The PMA application is based on scientific and clinical data demonstrating that the device is safe and effective for patients and users under usage prerequisites.
HEMOBLAST™ Bellows, a best in class hemostatic product that aims to control bleeding during surgical procedures (heart surgery, general surgery, orthopedic surgery, etc.) is thus now accessible to American surgeons.