medical device guru

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
Surgery and Surgical Robotics
Phoenix Children’s Is the First-Ever Health System in the U.S to Use Medtronic Stealth Autoguide Cranial Robotic Guidance Platform for Neurosurgery
Nationally ranked pediatric leader, Phoenix Children’s Hospital, is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide™ platform. Medtronic, a global leader in medical technology, chose Barrow Neurological Institute (BNI) at Phoenix...
January 22, 2020
Surgery and Surgical Robotics
TransEnterix Announces Submission of 510(k) to FDA for First Machine Vision System in Robotic Surgery 
TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the Company filed a 510(k) submission with an Intelligent Surgical Unit (ISUTM)1 that is designed...
January 16, 2020
Surgery and Surgical Robotics
Machine Keeps Livers Alive for a Week, Revives Injured Ones
Researchers from the UniversityHospital Zurich, ETH Zurich, Wyss Zurich and the University of Zurich have developed a machine that repairs injured human livers and keeps them alive outside the body for one week. This breakthrough may increase the number of...
January 15, 2020
Surgery and Surgical Robotics
Virtual Incision Announces $20 Million Financing to Advance First-of-its-Kind Surgical Mini-Robot 
Virtual Incision Corporation, a medical device company pioneering a first-of-its-kind miniaturized surgical robot, announced it has raised $20 million in a Series B+ financing led by returning investor Bluestem Capital, with participation from returning investor PrairieGold Venture Partners, as well...
January 8, 2020
Surgery and Surgical Robotics
Medtronic Warns of Mazor X Detachment Issue in Robotic Surgery
Users of Medtronic’s Mazor X Surgical System may experience a hardware detachment problem in which a system piece unexpectedly releases from the OR table, according to an urgent field safety notice issued by the company in December. Medtronic said it had received...
January 7, 2020
Surgery and Surgical Robotics
Interscope Announces New FDA Clearance of the EndoRotor, for Use in Airway Procedures Including in Interventional Pulmonology
Interscope, Inc. announced today the receipt of marketing clearance from the FDA for the EndoRotor® System to commercialize Pulmonary indications.  Interscope innovated the first flexible microdebrider for use by medical specialists in the digestive tract with reported results reducing the need...
January 2, 2020
Surgery and Surgical Robotics
Foresee-X Augment Reality Solution from SURGLASSES Is Registered with the FDA and Ready for Trauma Treatment
Foresee-X is a set of smart surgical glasses with functionality based on augmented and mixed reality technologies. This device was developed by SURGLASSES, also known as Taiwan Main Orthopaedic Biotechnology Co. Ltd., and has received IEC60601-1-2 and ISO 13485 certifications. It...
January 2, 2020
Surgery and Surgical Robotics
Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery
Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery....
December 26, 2019
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