medical device guru

Surgery and Surgical Robotics

New View Surgical, Inc. Closes $12.1M Series B-1 Financing, Readies Limited Market Release of its VisionPort™ System For Minimally Invasive Surgery

New View Surgical, Inc., an emerging medical device company developing proprietary imaging and access technologies for minimally invasive surgery (MIS), announced the closure of a $12.1M Series B-1 equity financing round to fund the commercialization of its VisionPort™ System. The...

November 22, 2022

Surgery and Surgical Robotics

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...

November 15, 2022

Surgery and Surgical Robotics

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...

November 14, 2022

Surgery and Surgical Robotics

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...

November 7, 2022

Surgery and Surgical Robotics

NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use

NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG...

October 25, 2022

Surgery and Surgical Robotics

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...

October 25, 2022

Surgery and Surgical Robotics

Axoft Launches Brain Implant Technology to Treat Long-Term Neurological Disorders and is Granted FDA Breakthrough Device Designation

Axoft, a neurotechnology company, launched and announced FDA Breakthrough Device designation for its brain-machine interface (BMI) to better treat neurological disorders. The company secured $8 million in capital to fund pre-clinical studies with the FDA and to scale up prototypes...

October 18, 2022

Surgery and Surgical Robotics

Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain

Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation...

October 13, 2022

Surgery and Surgical Robotics

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...

October 11, 2022