medical device guru

Surgery and Surgical Robotics

A New Suturing Tool, Endomina System, from Endo Tools Therapeutics, Gains FDA Clearance

Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices for use by gastroenterologists, today announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of the endomina® system, designed for endoscopic placement of suture(s) and approximation of soft tissue...

February 4, 2022

Surgery and Surgical Robotics

Neuros Medical Receives FDA Breakthrough Device Designation for its Novel Altius High Frequency Nerve Block System

Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain...

July 5, 2021

Surgery and Surgical Robotics

Interventional Systems Receives FDA Clearance for Miniature Surgical Robot for Needle-based Procedures

Interventional Systems announced Micromate, the world’s smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA. Micromate is a table-mounted medical robot for interventional procedures with a universal instrument guidance solution that...

July 5, 2021

Surgery and Surgical Robotics

Preceptis Medical Announces Publication of Positive Results from Pediatric In-Office Study of the Hummingbird Tympanostomy Tube System (TTS)

Preceptis Medical, Inc., a company dedicated to helping ENT surgeons improve how they care for children, today announced positive results from a prospective, multicenter study designed to assess in-office pediatric ear tube placement with the FDA-cleared Hummingbird Tympanostomy Tube System...

March 14, 2021

Surgery and Surgical Robotics

FDA Grants Breakthrough Device Designation for Anuncia’s Cerebral Spinal Fluid Treatment

Anuncia Inc., an emerging leader in Cerebral Spinal Fluid (CSF) management, received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow™ System Mini intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and...

March 7, 2021

Surgery and Surgical Robotics

Fusion Robotics Wins FDA Clearance for 3D Imaging Robotic Targeting System

Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S. market. The Fusion Robotics System addresses the key limitations...

February 28, 2021

Surgery and Surgical Robotics

DePuy Synthes Receives 510(k) FDA Clearance for VELYS Robotic-Assisted Solution Designed for Use with the ATTUNE Total Knee System

Today, The Johnson & Johnson Medical Devices Companies announced that DePuy Synthes has received 510(k) clearance from the U.S. Food and Drug Administration for the VELYS Robotic-Assisted Solution designed for use with the ATTUNE Total Knee System and its cleared...

January 19, 2021

Surgery and Surgical Robotics

NeuroOne Medical Announces First Human Commercial Use of its Evo Cortical Electrode at Mayo Clinic

NeuroOne Medical Technologies Corporation (OTCQB: NMTC; NeuroOne), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today the first human commercial use of its Evo Cortical Electrode at Mayo Clinic in Rochester, Minnesota....

December 3, 2020

Surgery and Surgical Robotics

Zimmer Biomet Picks up Chest Surgery Toolmaker A&E Medical for $250M

Vance Street Capital LLC (“Vance Street”) is pleased to announce it has completed the sale of A&E Medical Corporation (“A&E Medical”) to Zimmer Biomet (NYSE: ZBH) (“Zimmer”), a global leader in musculoskeletal healthcare, for $250 million. The transaction marks the...

December 2, 2020