In Brief: Possis Medical
This article was originally published in The Gray Sheet
Executive Summary
Possis Medical: Submits revised 510(k) to FDA for use of its AngioJet Rapid Thrombectomy System in peripheral vessels. The submission was made in response to questions raised by FDA on an initial 510(k) submitted in March ("The Gray Sheet" June 24, In Brief)...
You may also be interested in...
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.