medical device guru

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

Surgery and Surgical Robotics

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...

September 12, 2022

Surgery and Surgical Robotics

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...

September 8, 2022

Surgery and Surgical Robotics

Magnus Medical Receives FDA Clearance for the SAINT Neuromodulation System

Magnus Medical, Inc., a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, announced it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the SAINTTM Neuromodulation System for the treatment of major...

September 6, 2022