medical device guru

Surgery and Surgical Robotics
Ocutrx’s Oculenz Advances from AR Headset to Full Surgery Visualization Theatre
The maker of breakthrough augmented-extended reality (AR/XR) glasses that provide a radically new surgical viewing experience for retinal surgeons and patients alike, is launching new technology that provides the most modern options for surgery visualization and to remove “pain” for...
June 10, 2020
Surgery and Surgical Robotics
CMS Approves SINUVA Sinus Implant for Reimbursement with New C-Code and Pass-Through Payment Status
Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved SINUVA® (mometasone furoate) Sinus Implant for transitional pass-through payment status...
June 9, 2020
Surgery and Surgical Robotics
Titan Medical Announces Development and License Agreements With Medtronic and Senior Secured Loan
Titan Medical Inc. (“Titan” or “Titan Medical”) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of single-port robotic surgical technologies, announces that it has entered into a development and license agreement with Medtronic plc...
June 4, 2020
Surgery and Surgical Robotics
3NT Medical Announces FDA Clearance for Colibri Endoscopy System
3NT Medical, a privately-held corporation dedicated to developing single-use specialized endoscopes for the diagnosis and treatment of ear, nose and throat (ENT) disorders, announced today the FDA 510(k) clearance for the Colibri™ Micro ENT Scope, the world’s first single-use endoscope...
June 2, 2020
Surgery and Surgical Robotics
Gynesonics Receives FDA Clearance to Market Next Generation Sonata System 2.1 
Gynesonics, a women’s healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its next generation Sonata® System 2.1...
May 28, 2020
Surgery and Surgical Robotics
SMART Medical Systems Receives FDA Clearance for Its G-EYE Colonoscope
SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its flagship product, the G-EYE® Colonoscope. The G-EYE® colonoscope is a standard colonoscope which SMART remanufactures by installing its proprietary G-EYE® balloon on...
May 26, 2020
Surgery and Surgical Robotics
Nevro Announces CE Mark Approval of Senza Omnia Spinal Cord Stimulation System to Treat Chronic Pain
Nevro Corp., a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received CE mark approval for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system. “Following a successful launch in the...
May 14, 2020
Surgery and Surgical Robotics
Ambu Launches New Single-Use Cystoscope for Improved Workflow and Enhanced Productivity Benefits
Ambu Inc., a rapidly growing medical device maker and pioneer of sterile, single-use endoscopes, introduced today a new single-use cystoscope. The Ambu® aScope™ 4 Cysto will give urologists immediate access to a single-use cystoscope that can be used for procedures...
May 12, 2020
Surgery and Surgical Robotics
FDA Clears New Mechanical Thrombectomy Platform
Control Medical Technology announced the FDA cleared the Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral vessels. Blood clot removal (thrombectomy) is a common procedure. Coronary thrombectomy is associated with acute myocardial infarction (AMI),...
May 6, 2020
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