medical device guru

Surgery and Surgical Robotics

Pelvital Announces FDA Clearance of Flyte Pelvic Floor Device

Pelvital, a medical technology company focused on women’s health, announced it has received U.S. Food and Drug Administration (FDA) clearance for Flyte, a first-of-its-kind, non-invasive, intravaginal home-use device that is intended for strengthening of the pelvic floor muscles, which has...

August 25, 2020

Surgery and Surgical Robotics

U.S. FDA Grants Ethicon Breakthrough Device Designation for Monarch-enabled NeuWave Microwave Ablation Technology

Ethicon, part of the Johnson & Johnson Medical Devices Company, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for transbronchial microwave ablation technology using robotic-assisted bronchoscopy, which is currently under development. The Breakthrough Devices Program...

July 31, 2020

Surgery and Surgical Robotics

Ambu Wins FDA Clearance for Single-use Duodenoscope Product

Ambu Inc., a rapidly growing medical device maker and pioneer of sterile, single-use endoscopes, announced today that the Ambu® aScope™ Duodeno has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). “At Ambu, we are determined to advance patient safety...

July 23, 2020

Surgery and Surgical Robotics

FDA Approves Channel Medsystems’ Women’s Health Cryotherapy Device

Channel Medsystems, a company dedicated to bringing innovation to the delivery of women’s healthcare, today announced that the U.S. Food and Drug Administration (FDA) recently approved the newest Cerene Cryotherapy Device, a next-generation technology for the treatment of heavy menstrual...

July 22, 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

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