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
Diagnostics & Healthcare News
Dimer Offers New Germ-Killing Robot to Disinfect Airplanes at Key US Airports to Protect Passengers from Coronavirus Outbreak
Dimer UVC Innovations is offering its GermFalcon®, a germ-killing robot that sanitizes airplanes, to assist airlines and federal agencies disrupt the spread of a new pneumonia-like illness originating in the Wuhan region of China. The service is being offered at no...
January 23, 2020
Cardiovascular / Cardiology
VivaLNK Announces World’s First FDA Cleared Wearable ECG Sensor Platform
VivaLNK, a leading provider of connected healthcare solutions, today announces it received FDA clearance for its Continuous ECG Platform. Consisting of reusable wearable ECG sensors and associated software development kit (SDK), the sensor platform gives developers and providers direct control...
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
Cardiovascular / Cardiology
BioCardia Announces FDA Clearance for Morph DNA Catheter to Guide Cell Delivery into Heart Tissue
BioCardia (BCDA)®, Inc. , a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™...
January 20, 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
Orthopedics and Spine
CoreLink Surpasses 5,000 Implants With Proprietary 3D Printed Technology 
CoreLink, LLC, a leading designer and manufacturer of spinal implant systems, today announced the implantation of over 5,000 3D printed devices using their proprietary Mimetic Metal® technology. Mimetic Metal is an additively manufactured technology that combines a lattice framework and inner trabecular...
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
Diagnostics & Healthcare News
Phagenesis Wins FDA Breakthrough Nod for Phagenyx System for Restoring Swallowing
Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx System is a...
January 14, 2020
1 2 3 111