medical device guru

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

Surgery and Surgical Robotics

FDA Clears Paragonix Technologies’ LUNGguard for Donor Lung Preservation

Paragonix Technologies, Inc. today announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2. The Paragonix LUNGguard Donor Lung Preservation System is intended to be used for the...

February 10, 2020

Surgery and Surgical Robotics

LapTrainer Mixed Reality Simulator for Laparoscopy Training Unveiled

The long-term collaboration between KARL STORZ and VirtaMed in the domain of medical simulation reaches a milestone with the development of LapTrainer, a cutting-edge hybrid simulator designed to maximize the benefits of simulation in laparoscopy. The new simulator offers a unique...

February 4, 2020

Surgery and Surgical Robotics

BIONIK Laboratories Announces Regulatory Approval and First Sale of its InMotion ARM Robotic Technology by its Exclusive Distributor in South Korea

BIONIK Laboratories Corp., a robotics company focused on providing rehabilitation and assistive technology solutions to individuals with neurological and mobility challenges from hospital to home, today announced it has received regulatory approval in South Korea, and that its exclusive distributor...

January 30, 2020

Surgery and Surgical Robotics

GT Medical Technologies Announces FDA Clearance of Expanded Indication for GammaTile Therapy 

GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for GammaTile® Therapy. Patients with newly diagnosed malignant brain tumors...

January 27, 2020

Surgery and Surgical Robotics

Cardinal Begins Recall of 9.1M Surgical Gowns Amid Sterility Concerns 

Details of the quality problems and Cardinal’s response to them have trickled out in January. Cardinal told customers it learned of problems with environmental conditions at a site that makes gowns last week, leading to a voluntary product hold. At...

January 23, 2020