FDA clears Onward’s ARC-EX System for home use in spinal cord injury care
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the expanded use of Onward Medical’s ARC-EX System, now…
Orthopedic Devices
-
-
Zimmer Biomet secures FDA approval for ROSA Knee with OptimiZe system
Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe technology.…
-
FDA grants breakthrough status to Augurex’s axSpA diagnosis test
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Augurex Life Sciences’ SPINEstat 14-3-3eta Autoantibody Multiplex…
-
FDA grants 510(k) clearance to Surgical Theater’s spine platform
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Surgical Theater's next-generation platform, SyncAR Spine. The decision…
-
Zimmer Biomet’s iTaperloc Complete and iG7 Hip System approved in Japan
Zimmer Biomet has secured approval from Japan's Pharmaceutical and Medical Devices Agency (PMDA) for its iTaperloc Complete and iG7 Hip…
-
FDA clears Amber Implants’ vertebral augmentation system
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Amber Implants’ VCFix Spinal System, intended for treating…
-
Centinel Spine’s prodisc C Vivo and C Nova systems obtain MDR certification
Centinel Spine has received certification under the European Union (EU) Medical Device Regulation (MDR) for its prodisc C Vivo and…
-
Highridge purchases interbody fusion and pedicle screw systems from Accelus
Highridge Medical has purchased the FlareHawk and Toro expandable interbody fusion systems, along with the LineSider pedicle screw system from…
-
Interventional and HICREN gain approval for miniature spinal robot in China
The Sino-European MicroRobotics (Shanghai) (SEMR) joint venture (JV) has obtained regulatory approval for the Intelligent SpinePecker miniature spinal surgical robot…
-
SetPoint Medical secures $140m for commercialisation of RA therapy
SetPoint Medical has secured $140m through private financing, earmarked for the commercial rollout of the SetPoint System, a neuroimmune modulation…
