medical device guru

Orthopedics and Spine
Medtronic to acquire Titan Spine
Medtronic said last week that it agreed to acquire Titan Spine for an undisclosed amount. Mequon, Wis.-based Titan Spine makes a line of titanium interbody fusion devices featuring a surfacing technology it developed to encourage the ingrowth of bone into the...
May 13, 2019
Diagnostics & Healthcare News
First Medical Device Treatment for Childhood ADHD Cleared by FDA
NeuroSigma won de novo clearance from the FDA last week to put the first medical device for treating attention-deficit hyperactivity disorder on the U.S. market. Los Angeles-based NeuroSigma makes the Monarch eTNS system, which is designed to deliver mild electrical signals through a...
April 22, 2019
Orthopedics and Spine
Exactech Announces First Successful Surgeries Using InterSep Bone Void Filler
Exactech, a developer and producer of bone and joint restoration products for extremities, hip, and knee, announced today the successful first surgery using its new InterSepTM calcium sulfate bone void filler. One of the newest additions to Exactech’s infection-related solutions, InterSep is...
April 17, 2019
Diagnostics & Healthcare News
Elucent Medical Wins FDA Clearance for New Breast Surgery Navigation System
Elucent Medical, a company dedicated to developing better pathways for breast cancer care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the clinical use of the company’s EnVisio™ Surgical Navigation System. Placed at...
April 15, 2019
Diagnostics & Healthcare News
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
Cardiovascular / Cardiology
FDA Approves First New Therapy to Treat Heart Attacks in Years
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage...
April 8, 2019
Cardiovascular / Cardiology
Genetesis CardioFlux Platform Receives FDA 510(k) Clearance
Genetesis, a company based in Mason, Ohio, won FDA clearance for its cardiac imaging offering that combines the CardioFlux magnetocardiograph with the the integrated Faraday Analytical Cloud (FAC). The technology is intended to be used by ER physicians and cardiologists to...
April 2, 2019
Diagnostics & Healthcare News
Itamar Medical Launches Next-Generation WatchPAT System for Home Sleep Apnea Testing
Itamar Medical Ltd., a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced the launch of WatchPAT 300, the next generation WatchPAT system for home sleep apnea...
March 27, 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
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