FDA Clearance Awarded to Tyber Medical for NiTy+ One-Shot Staple Fixation System

Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot™ Staple Fixation System. The NiTy+ One-Shot is the first instrument of its kind in the bone-fixation device market to feature a…

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Xironetic Receives FDA Clearance for Augmented Reality Surgical Software

Xironetic, an early-stage healthcare technology company, today announced its IntraOpVSP™ augmented reality (AR) visualization software for complex surgeries has received clearance from the U.S. Food and Drug Administration (FDA). IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR headsets, helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on…

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Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSit

Allotrope Medical™ Inc., a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. For the past year, StimSite has been used by surgeons to help locate and identify ureters through electrical stimulation. This designation, along with a proposed…

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EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

EndoStim, a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. FDA Breakthrough Device Designation is intended to provide patients and health care providers with timely access to…

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XACT Robotics® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit

XACT Robotics®, developer of the world’s first and only comprehensive robotic system for interventional procedures, announced that its ACE Xtend™ Remote Control Unit received U.S. Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE® Robotic System remotely from the control room. The first-of-its-kind feature for CT-guided percutaneous procedures…

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Aerin Medical Receives FDA Clearance of Next-Generation RhinAer® Stylus for Treatment of Patients with Chronic Rhinitis

Aerin Medical Inc., a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. RhinAer is a non-invasive, temperature-controlled radiofrequency technology that durably treats the causes of rhinorrhea (runny nose), post-nasal drip…

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Serpex Medical Announces Second FDA 510(k) Clearance of Its Steerable Endobronchial Instrument Platform – The Compass Steerable Needle

Serpex Medical announced U.S. FDA 510(k) clearance of its Compass Steerable Needles – steerable biopsy needles that enable precise access to lung nodules in the intrapulmonary region. Serpex Medical seeks to leverage the power of steerable instruments to enable greater precision and access to improve the diagnosis and treatment of lung cancer. The clearance of…

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eCential Robotics Receives FDA Clearance for its Surgical Robotic Platform for Spine Surgery

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform in the United States. After having recently concluded partnership with US implant companies, eCential Robotics…

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CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System

CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH).  “We are…

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Preceptis Medical Receives FDA Clearance for Expanded Labeling for Hummingbird System

Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive options for pediatric patients, announced U.S. FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children 6-24 months, this new labeling allows in-office procedures in all children six…

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