Biom’Up said today it won FDA premarket approval for its Hemoblast Bellows hemostatic product designed to control bleeding during surgeries including cardiac, general and orthopedic procedures. The Paris-based company’s flagship Hemoblast Bellows product is a ready-to-use hemostatic solution that is usable several times during surgery to reduce bleeding. Approval of the hemostatic came based on […]
Biom'Up
biom’up announced enrollment of first patient in clinical investigation of HEMOBLAST Bellows
biom’up announced the enrollment of the first patient in their prospective, randomized, controlled, multicenter, pivotal, clinical investigation evaluating the safety and efficacy of HEMOBLAST™ Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries. HEMOBLAST™ Bellows is an investigational device, not currently for sale in the US that is intended for use in surgical procedures as […]
Biom’Up announced it has received FDA clearance for the HEMOBLASTTM Bellows IDE pivotal clinical trial design
The prospective, randomized, controlled, multi-center clinical investigation evaluates the safety and efficacy of HEMOBLASTTM Bellows, the company’s novel hemostat, in cardiothoracic, abdominal, and orthopedic lower extremity surgeries. The study meets the FDA requirement for reliability by establishing the eligibility of the target bleeding site and achievement of hemostasis based on the SPOT GRADETM, a validated […]
McKesson to pay $2B for PSS World Medical | Wall Street Beat
McKesson (NYSE:MCK) agreed to pay $29 per share for PSS World Medical (NSDQ:PSSI) and its medical supplies business in a deal worth $2.1 billion.