medical device guru

Surgery and Surgical Robotics

Medtronic Finally Unveils its New Robot-Assisted Surgery System

Medtronic has a robot-assisted surgery platform that is upgradeable, modular and able to perform both RAS and laparoscopic applications —  an obvious answer to the da Vinci SP robot-assisted surgery platform made by Intuitive Surgical. That appears to be the message...

September 24, 2019

Cardiovascular / Cardiology

Cardiovascular Systems, Inc. Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip 

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced U.S. Food and Drug Administration (FDA) PMA approval of the new ViperWire Advance® Coronary...

September 24, 2019

Cardiovascular / Cardiology

BIOLIFE4D Bioprints Small Human Heart for the First Time in the U.S.

BIOLIFE4D, one of the pioneers in the bioprinting field, has been able to bioprint a miniature human heart – making it the first U.S. company to successfully achieve this. The company’s mission is to create a fully functioning human heart through...

September 23, 2019

Surgery and Surgical Robotics

Globus Medical Acquires StelKast, Develops Orthopedic Surgery Robotics

Globus Medical Inc. last week acquired most of the assets of privately held orthopedics manufacturer StelKast Inc. for $24.1 million. The purchase price could increase by $4.3 million if certain product and sales milestones are met, including a system for...

September 23, 2019

Biologics, Wound Care, Infection Prevention

Self-Sterilizing Polymer Proves Effective Against Drug-Resistant Pathogens 

Researchers from North Carolina State University have found that an elastic polymer possesses broad-spectrum antimicrobial properties, allowing it to kill a range of viruses and drug-resistant bacteria in just minutes – including methicillin-resistant Staphylococcus aureus (MRSA). “We were exploring a different approach...

September 23, 2019

Surgery and Surgical Robotics

Viseon, Inc. Announces US FDA Clearance and Clinical Use of its Advanced High-Definition Real Time Imaging Technology for Minimally Invasive Spine Surgery

Viseon, Inc. today announced US FDA clearance and initial clinical use of their Voyant System, integrating minimally invasive surgical (MIS) access with real time high definition imaging technology for more efficient procedural workflow, which enhances a clinician’s intraoperative visualization, providing...

September 19, 2019

Cardiovascular / Cardiology

Biotronik First to Land MDR Certification for a High-Risk Device

Biotronik said that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. The newly certified device is Biotronik’s Renamic programmer software, which enables physicians to program and test...

September 19, 2019

Diagnostics & Healthcare News

Minimally Invasive Biopsies Provide Maximum Pathology Data

Current pathology techniques for analyzing biopsy tissues are lacking in their ability to detect cancer in small samples. Being able to rapidly study the distribution of protein expression within cells, gathered from minuscule samples, could be an important tool for...

September 19, 2019

Cardiovascular / Cardiology

Saranas Launches Early Bird® Bleed Monitoring System in the U.S.

Saranas, Inc. announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors....

September 19, 2019