medical device guru

Cardiovascular / Cardiology
First US Patients Treated Using the CardioFocus HeartLight X3 Ablation System
CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm...
June 19, 2020
Cardiovascular / Cardiology
Neovasc Closes $11.5 Million Offering
Neovasc Inc. (“Neovasc” or the “Company”), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, announced today that it has closed its previously announced registered direct...
June 17, 2020
Diagnostics & Healthcare News
LifeScan Announces OneTouch Verio Reflect Meter U.S. Launch
LifeScan, a world leader in blood glucose monitoring and maker of the iconic OneTouch® brand, today announced the U.S. launch of OneTouch Verio Reflect®, the only meter with a Blood Sugar Mentor™ feature that gives people with diabetes personalized real-time guidance...
June 11, 2020
Cardiovascular / Cardiology
Shockwave Medical Announces That CMS Has Created New Codes for Intravascular Lithotripsy
Shockwave Medical, Inc., a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the Centers for Medicare & Medicaid Services (CMS) has issued new codes for IVL procedures performed in...
June 11, 2020
Orthopedics and Spine
4WEB Medical Announces FDA 510(k) Clearance of Stand-Alone Anterior Lumbar Interbody Fusion Device
4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design that utilizes its proprietary Truss Implant Technology™, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...
June 10, 2020
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
Orthopedics and Spine
GTX medical Granted FDA Breakthrough Device Designation for Go-2 Targeted Epidural Spinal Stimulation (TESS) System
GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system which was designed to promote the recovery of leg motor functions and neurological control in adults with...
June 9, 2020
Diagnostics & Healthcare News
Nuvaira Announces FDA Breakthrough Designation for AIRFLOW-3 Pivotal Trial Device
Nuvaira, a developer of novel therapeutic strategies to treat obstructive lung diseases, has announced that its Nuvaira® Lung Denervation System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA).  This program creates an expedited...
June 8, 2020
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