AOTI secures 510(k) clearance for expanded use of wound management system
AOTI’s NEXA Negative Pressure Wound Therapy (NPWT) system has been granted 510(k) clearance to extend its indications of use by the US Food and Drug...
FDA clears Camber Spine’s SPIRA-A Integrated Fixation System
Camber Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its SPIRA-A Integrated Fixation System for anterior lumbar interbody...
Asensus Surgical wins FDA nod for surgical robot use in urology
Asensus Surgical received FDA 510(k) clearance for an expanded surgical robot indication. The Research Triangle Park, North Carolina-based company’s Senhance surgical system can now...
Spryte’s nOCT technology secures breakthrough device designation
Spryte Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its neuro-optical coherence tomography (nOCT) technology.Designed to revolutionise...
eCential Robotics wins FDA clearance for spine navigation robot
eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.Gières, France-based eCential Robotics designed the device as...
Inspire sleep apnea therapy wins CE mark under the EU Medical Device Regulation
Inspire Medical Systems announced its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation.Going into effect in 2021, the tighter...
Restore Medical’s ContraBand device receives FDA’s breakthrough status
Restore Medical has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its ContraBand system to treat left ventricle (LV) failure.The...
Positrigo’s NeuroLF brain PET system receives FDA clearance in the US
Positrigo, a Swiss based company developing nuclear medical imaging devices to advance functional brain imaging, has achieved a significant milestone with the U.S. Food...
FDA clears Providence Medical’s CORUS PCSS in cervical spine surgery
Providence Medical Technology has received clearance from the US Food and Drug Administration (FDA) for its CORUS Posterior Cervical Stabilization System (PCSS), designed to...