medical device guru

Surgery and Surgical Robotics

New Biomedical Review Finds Failure Rate in Some Surgical Mesh Treatments Unacceptably High

Failure rates in some treatments using surgical mesh are unacceptably high according to a newly published comprehensive biomedical review that considers the findings from peer-reviewed scientific articles assessing its use. In addition, the review concludes that more experiments should have...

September 18, 2018

Surgery and Surgical Robotics

Intuitive Surgical Submits New Robotic-Assisted Platform to FDA for Obtaining Lung Biopsies

Intuitive Surgical, Inc., the pioneer and a global technology leader in robotic-assisted, minimally invasive surgery, today announced it has submitted a premarket notification to the U.S. Food and Drug Administration (FDA) for the company’s new flexible robotic-assisted, catheter-based platform, designed to navigate...

September 6, 2018

Surgery and Surgical Robotics

Ultrasound-Guided Transcervical Fibroid Ablation System FDA Cleared 

Gynesonics, a women’s healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, today announced that it has received 510(k) clearance from the FDA to market its Sonata® Sonography-Guided Transcervical Fibroid Ablation (Sonata) System. The Sonata System...

August 24, 2018

Surgery and Surgical Robotics

7D Surgical’s Cranial Machine-Vision Guided Surgical System FDA Approved

7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module.  This achievement is a crucial step in the commercial launch of 7D Surgical’s innovative Machine-vision Image Guided Surgery...

August 13, 2018

Surgery and Surgical Robotics

Implantable Surgical Mesh may cause Autoimmune Disorders

Surgical mesh implants, often used for hernia or gynecological repair, may be the reason so many patients report symptoms of an autoimmune disorder, according to a University of Alberta rheumatologist. ‘In my practice, I studied 40 patients who had mesh...

August 1, 2018

Surgery and Surgical Robotics

Novel Intracranial Fluid Management System Receives 510(k)

IRRAS AB, a commercial-stage medical technology company focused on developing and commercializing transformative treatments to manage intracranial fluids, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for IRRAflow, its integrated, closed medical device system that...

July 17, 2018

Surgery and Surgical Robotics

Digital Surgery’s AI Platform Will Guide Surgical Teams Through Complex Procedures

Digital Surgery, a health tech company shaping the future of surgery through the convergence of surgical expertise and technology, today announced it has developed and successfully demonstrated the world’s first real-time, dynamic artificial intelligence (AI) system designed for the operating...

July 16, 2018

Surgery and Surgical Robotics

Onkos Surgical and Insight Medical Systems Team Up On an Augmented Reality Surgical System

Insight Medical Systems has teamed up with Onkos Surgical, Inc. to explore opportunities to apply Insight Medical’s ARVIS™ (Augmented Reality Visualization and Information System) in musculoskeletal oncology. The companies are working on a pilot project to assess the technology for use in tumor...

July 11, 2018

Surgery and Surgical Robotics

FDA Clearance for Embolx’s Next Gen Sniper Balloon Occlusion Microcatheter

Embolx, Inc., a medical device company developing microcatheters for arterial embolization procedures, today announced that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its next generation family of Sniper® Balloon Occlusion Microcatheters,...

July 9, 2018