1. Cytosorbents opens new U.S. manufacturing facility
CytoSorbents announced in a June 12 press release that it has opened a new manufacturing facility in Monmouth Junction, N.J. with the company’s ISO 13485:2003 certification. The new facility is expected to quadruple production capacity and will accelerate margin expansion and drive operating profitability. CytoSorbents currently manufactures its CytoSorb Blood purification technology that treats deadly inflammation in critically-ill and cardiac surgery patients.
2. Centinel Spine wins 510(k) clearance
Centinel Spine has won FDA 510(k) clearance for its FLX Platform of Integrated Interbody and non-integrated interbody fusion device, according to a June 7 press release. The FLX devices are 3D printed, all-titanium devices that feature solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility. The devices also use a Fuse-Thru trabecular scaffold that is designed to promote bony in-growth and on-growth throughout the implant.
3. Prescient Surgical gets CE Mark approval
Prescient Surgical announced in a June 12 press release that it has received CE Mark approval for its CleanCision technology. CleanCision fights and defends against the sources of surgical site infections. The approval allows the company to be available to European hospital systems. CleanCision received FDA 510(k) clearance in the U.S. in October last year and is ISO 134385:2016 certified.