medical device guru

Surgery and Surgical Robotics

SMART Medical Systems Receives FDA Clearance for Its G-EYE Colonoscope

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its flagship product, the G-EYE® Colonoscope. The G-EYE® colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE® balloon on...

May 26, 2020

Surgery and Surgical Robotics

Nevro Announces CE Mark Approval of Senza Omnia Spinal Cord Stimulation System to Treat Chronic Pain

Nevro Corp., a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received CE mark approval for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system. “Following a successful launch in the...

May 14, 2020

Surgery and Surgical Robotics

Ambu Launches New Single-Use Cystoscope for Improved Workflow and Enhanced Productivity Benefits

Ambu Inc., a rapidly growing medical device maker and pioneer of sterile, single-use endoscopes, introduced today a new single-use cystoscope. The Ambu® aScope™ 4 Cysto will give urologists immediate access to a single-use cystoscope that can be used for procedures...

May 12, 2020

Surgery and Surgical Robotics

FDA Clears New Mechanical Thrombectomy Platform

Control Medical Technology announced the FDA cleared the Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral vessels. Blood clot removal (thrombectomy) is a common procedure. Coronary thrombectomy is associated with acute myocardial infarction (AMI),...

May 6, 2020

Surgery and Surgical Robotics

Allurion Technologies Announces Submission of US Premarket Approval Application for its Flagship Elipse Gastric Balloon

Allurion Technologies, an established leader in the development of innovative, proven, and trusted weight loss experiences, today announced the Premarket Approval (PMA) submission of its flagship Elipse gastric balloon. The company had previously announced the successful completion of its landmark FDA...

April 7, 2020

Surgery and Surgical Robotics

TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery

TransEnterix, Inc., a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company received 510(k) clearance for the Intelligent Surgical Unit (ISUTM) that enables machine vision capabilities...

March 19, 2020

Surgery and Surgical Robotics

Endologix Announces FDA Approval of AFX Endovascular AAA System

Endologix, Inc. (Nasdaq: ELGX), developer and marketer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its next generation product, the AFX™ Endovascular AAA System, for the treatment of...

March 16, 2020

Surgery and Surgical Robotics

Aerin Medical Announces FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis 

Aerin Medical Inc., a company focused on minimally invasive solutions for chronic nasal conditions, today announced U.S. Food and Drug Administration (FDA) clearance and U.S. launch of the company’s second product, the RhinAer™ Stylus, an innovative device for nonsurgical treatment...

March 9, 2020

Surgery and Surgical Robotics

Baxter Launches Peri-Strips Dry With Secure Grip Technology for Reliable Staple Line Reinforcement in Surgical Procedures 

Baxter International Inc., a global leader in advancing surgical innovation, announced 510(k) clearance from the U.S. Food and Drug Administration for a new generation of its Peri-Strips Dry with Veritas Collagen Matrix (PSDV) product, known as PSDV with Secure Grip. Now available with...

March 2, 2020