Tag Archive for: breakthrough device designation

Xeltis announces FDA Breakthrough Device Designation for aXess and first patient treated in US pivotal trial

/in

Designation recognizes aXess has the potential of providing a more effective vascular access option for dialysis patients, bringing significant advantages over current therapies First patient treated in US pivotal trial, marking significant clinical milestone EINDHOVEN, The Netherlands, 14 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living […]

Read more

Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2

/in

RENOVITE® BMP-2 is being developed as an alternative to bone graft materials for interbody spinal fusion It is the first product based on RENOVITE®, Renovos’ novel nanoclay therapeutic delivery platform for precision regenerative medicine Keele, UK, 4 January 2024 – Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating […]

Read more