medical device guru

Surgery and Surgical Robotics

Paradromics Raises $33 Million in Funding, Achieves Breakthrough Medical Device Designation from FDA

Paradromics Inc., the leading developer of high data-rate brain-computer interfaces (BCI), today announced a $33 million Series A funding round led by Prime Movers Lab. Additional investors include Westcott Investment Group, Dolby Family Ventures, and Green Sands Equity. The new funding will...

May 18, 2023

Surgery and Surgical Robotics

Neuvotion Secures an Additional $1.25M to Commercialize NeuStim™ Technology for Treating Stroke and Debilitating Injuries

Neuvotion, Inc. is an early-stage medical device company developing neurostimulation products for the rehabilitation, brain-computer interface, and physical therapy markets, today announced that it has received an additional $1.25M in funding, bringing cumulative funding to over $2.75M. Northwell Holdings, the venture investment arm of...

April 14, 2023

Surgery and Surgical Robotics

Synapse Biomedical Wins New Approval for Diaphragm Pacing System to Free Patients from Ventilators

Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for use in patients with spinal cord injuries who rely on mechanical ventilation. PMA is the most stringent type of...

April 5, 2023

Surgery and Surgical Robotics

Prolira Announces FDA Clearance of the DeltaScan® Brain State Monitor for Detecting Acute Encephalopathy (Acute Brain Failure), a Condition Affecting Millions of Hospitalized Patients 60 and Older

Prolira BV, a high-tech company committed to enabling early and effective treatment of patients at risk of developing acute brain failure, announced it has received 510(k) clearance from the Food and Drug Administration (FDA) for the DeltaScan® Brain State Monitor...

March 16, 2023

Surgery and Surgical Robotics

Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc., a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The...

January 31, 2023

Surgery and Surgical Robotics

Sonorous NV Uses New Device to Treat Patients with Symptomatic Cerebral Venous Diseases

Sonorous NV, Inc. Chairman, Dave Ferrera, announced treatment of the first patients in North America with the BossStent® device designed to treat patients with symptomatic cerebral venous diseases. The single-use, implantable device acts as an endoluminal prothesis that is placed into a cerebral venous...

December 19, 2022

Surgery and Surgical Robotics

NeurOptics’ Neurological Pupil index™ and Automated Pupillometry Included in Latest European Guidelines for Post-Resuscitation Care

NeurOptics’ Neurological Pupil index™ (NPi®) and automated pupillometry are now included in the updated 2021 European Resuscitation Council (ERC) and European Society of Intensive Care Medicine (ESICM) Guidelines for post-resuscitation care as an objective measurement supporting neurological prognosis in patients...

December 14, 2022

Surgery and Surgical Robotics

WISE Receives FDA Clearance for its WISE Cortical Strip Bringing Neuromonitoring to the Next Level

WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), announced the FDA clearance of its WISE Cortical Strip (WCS®), a single use medical device intended to be used on the brain surface for...

December 5, 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