medical device guru

Surgery and Surgical Robotics

Nexus Ultrasonic Surgical Platform from Misonix FDA Cleared

Misonix, Inc., a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today announced that it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for Nexus, its revolutionary ultrasonic surgical platform. Misonix will commence...

June 6, 2019

Surgery and Surgical Robotics

First-Ever Clinical Trial Initiated for Neural Interface that Turns Thoughts into Speech

Synchron, Inc. today announced the initiation of the first clinical trial for the Stentrode™, a minimally-invasive neural interface technology being investigated for restoration of communication in people with severe paralysis. The trial will evaluate the safety of Thought-to-Text™ technology in patients, by assessing...

April 9, 2019

Surgery and Surgical Robotics

Zimmer Biomet Receives FDA Clearance for Robotic ROSA One Spine System

Zimmer Biomet Holdings, Inc., a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries, strengthening the Company’s comprehensive ROSA® ONE Brain and...

March 25, 2019

Surgery and Surgical Robotics

FDA Warns Against Using Surgical Robots in Cancer Surgeries

The Food and Drug Administration on Thursday warned against the use of robotically assisted devices for mastectomies and other cancer surgeries, asserting the products may pose safety risks and result in poor outcomes for patients. The agency said it decided to issue...

March 4, 2019

Surgery and Surgical Robotics

Axilum Wins 510(k) Clearance for Robotic TMS System

Axilum Robotics, which specializes in the development of medical robots, announced that two weeks after the CE mark, it has received 510(k) clearance from the U.S. Food and Drug Administration to market the TMS-Cobot TS MV for the spatial positioning and...

February 27, 2019

Surgery and Surgical Robotics

Intuitive Surgical Gains FDA Clearance for Lung Cancer Biopsy Robot

Intuitive Surgical Inc. said last week that the U.S. Food and Drug Administration has cleared its Ion system. The robotic endoluminal system is designed to enable doctors to conduct minimally invasive biopsies deep within the lung. Ion includes an articulating...

February 25, 2019

Surgery and Surgical Robotics

J&J Acquires Robotic-Surgery Firm Auris for $3.4 Billion

Focused on creating the next frontier of surgery, Johnson & Johnson, today announced that Ethicon, Inc., entered into a definitive agreement to acquire Auris Health, Inc. for approximately $3.4 billion in cash. Additional contingent payments of up to $2.35 billion,...

February 13, 2019

Surgery and Surgical Robotics

Northwestern Memorial Hospital Performs First US Robotic Lung Volume Reduction Surgery

Northwestern Memorial Hospital is the first in the country to successfully complete robotic-assisted lung volume reduction surgery (LVRS) using the da Vinci Xi Surgical System® to remove diseased, emphysematous tissue within the lungs for the treatment of severe emphysema, a progressive form of...

January 21, 2019

Surgery and Surgical Robotics

TransEnterix Wins FDA Clearance for Senhance Ultrasonic Instruments

TransEnterix, Inc., a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced the Company received FDA 510(k) clearance for its Senhance Ultrasonic System. “Advanced energy devices are used within a high percentage...

January 15, 2019