Surgery and Surgical Robotics
Lazurite™ to Showcase its ArthroFree™ Wireless Camera System at Multiple Upcoming Conferences
Medical device and technology company Lazurite Holdings LLC announced that its ArthroFree™ wireless camera system for minimally invasive surgery will be available for viewing and hands-on demonstration at these four upcoming medical conferences: Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), March 16-19, in Denver (Booth 202) Global Surgical Conference & Expo…
Read MoreEvoEndo Announces US FDA 510(k) Clearance for their Single-Use, Unsedated Transnasal Endoscopy System
EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing and sale of the EvoEndo® Single-Use Endoscopy System. The clearance follows EvoEndo’s distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”), which will begin…
Read MoreRapid Medical Granted FDA Breakthrough Device Designation for Vasospasm Treatment
Rapid Medical’s Comaneci is the first device that allows physicians to monitor vessel expansion, apply incremental adjustments, and enhance treatment with combination therapeutics. With this unprecedented control, the FDA designated Comaneci as a breakthrough device–offering advantages over existing technology to improve safety and efficacy in cerebral vasospasm. Rapid Medical, a leading developer of advanced neurovascular…
Read MoreFirst Hospital on the East Coast to Perform Total Knee Replacement with THINK Surgical’s Next-Generation Robot System
Hackensack University Medical Center, a national leader in orthopedic care and robotic surgery, recently completed the first total knee replacement on the East Coast using the newest generation of the TSolution One robot from THINK Surgical. The system, manufactured by the Fremont, CA – based company features a true, active robot which supports a choice of knee implants…
Read MoreAmbu Announces FDA Clearance of Single-Use Gastroscope and Next-Generation Display Unit
Ambu announces the 510(k) regulatory clearance of the Ambu® aScope™ Gastro and Ambu® aBox™ 2 in the United States. aScope Gastro is Ambu’s first sterile single-use gastroscope and includes new advanced imaging and design features in a combined solution with next-generation display and processor technology. With HD capabilities, the aBox 2 will set a new…
Read MoreA 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 in the gastrointestinal tract on adult population. The endomina system is comprised of a universal…
Read MoreNeuros 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 of the lower limb of adult amputees. The FDA Breakthrough Device Program is intended to help patients…
Read MoreInterventional 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 allows physicians to continue using their preferred surgical instruments. Targeting is performed under live-imaging using…
Read MorePreceptis 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 (TTS). Peer-reviewed results from the study were published in Laryngoscope Investigative Otolaryngology. Outcomes from the study…
Read MoreFDA 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 life-threatening condition affecting more than 1 million U.S. patients. Elsa Abruzzo, President of Anuncia Inc., stated,…
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