Bacterin's OsteoSelect PLUS Demineralized Bone Matrix Putty has received 510(k) clearance from the FDA. The product, which includes demineralized cortical chips and OsteoSelect Putty, is set for launch in the fourth quarter.
Abyrx has entered into a distribution deal with SurgiCor to help bring its hemostatic bone putty products to orthopedic and spinal surgeons across the U.S. The deal covers Abyrx's Hemasorb, Hemasorb Plus, Hemasorb Apply and AHBP.
The FDA has granted CryoLife conditional investigational device exemption approval for its PerClot system. The company said the device, which consists of absorbable polysaccharide granules, is designed for use as an ancillary hemostatic tool when conventional methods to control bleeding during surgery are impractical or ineffective.
The FDA has released draft guidance governing a new voluntary program that would help clinical trial sponsors assess, prior to submitting an investigational device exemption application, whether the design of their pivotal study would lead to marketing approval. The guidance is up for comment through Sept. 12.