spinal implant News
-
ASTM F1582 - 98(2011) Standard Terminology Relating to Spinal Implants
1. Scope 1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses. 2. Referenced Documents (purchase separately) ASTM Standards E6 Terminology Relating to Methods of Mechanical Testing E1150 Definitions of Terms Relating to Fatigue Index Terms 0 Spinal implants; Terminology--medical/surgical systems/applications ICS ...
-
ASTM F2267 - 04(2011) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Intervertebral body fusion devices are generally simple geometric shaped devices, which are often porous or hollow in nature. Their function is to support the anterior column of the spine to facilitate arthrodesis of the motion segment. This test method is designed to quantify the subsidence characteristics of different designs of intervertebral body fusion devices since ...
-
Nanovis Awarded Nanotechnology Designation for Bioceramic Nanotube Surface.
CARMEL, Indiana (Oct 22, 2019) – Nanovis today announced that it received the first 510(k) clearance for a bioceramic nanotube surface that demonstrated the FDA requirements for nanotechnology. “We are delighted to receive such an important designation for this new class of nanotechnology. This nanotechnology plays an important role in achieving Nanovis’ goal to reduce the ...
By Nanovis
-
ASTM F2346 - 05(2011) Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
Artificial intervertebral discs are orthopaedic implants that replace degenerated natural intervertebral discs. Their function is to support the anterior column of the spine while allowing motion at the operated level. These test methods outline materials and methods for the characterization of the mechanical performance of different artificial intervertebral discs ...
-
Top 5 Mistakes Medical Device Inventors Make When They Have A New Idea
The hardest part of developing a new idea is getting started. But getting started without considering this list could cause major project setbacks. Contact me to discuss how I can help navigate the complicated product development cycle and bring your new idea to life. List Below: Hiring an engineer or firm without medical device experience. The nuances of medical devices and specific surgical ...
-
Nanovis Announces Commercial Launch of New Nanosurface Technology on Spinal Interbody Implants
CARMEL, Indiana. (July 30, 2019) – Nanovis today announced the commercial launch of its bioceramic nanotube enhanced FortiCore interbodies following a successful alpha launch. The FortiCore interbodies are designed with a unique, proprietary, patent protected bio-ceramic enhanced titanium nanotube surface. The nanotubes are applied to a deeply porous, fully interconnected titanium ...
By Nanovis
-
Nanovis Wins the Global Health & Pharma 2018 Technology Awards
CARMEL, Indiana. – Sept. 11, 2018 – Nanovis, a leader in nanomedicine for the spine, today announced a licensing agreement with the University of Nevada, Reno for a key nanosurface technology patent covering the use of ceramics on implants with nanopores. This foundational patent allows development of ceramics for medical implants with nanosurfacing that enhances cell binding and ...
By Nanovis
-
Wenzel Spine Announces Commercial Launch of the VariLift-LX
Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, expandable stand-alone alternatives to traditional spinal fusion, announced today the full commercial availability of the VariLift-LX System throughout the U.S. VariLift®-LX represents the next generation of Wenzel Spine’s innovative product lines of Expandable Stand-Alone interbody fusion ...
-
How to License or Sell Your Medical Device Intellectual Property
Part I – Presenting Your Idea Anywhere during the product development cycle, it may make sense to discuss your medical device with potential acquirers. Licensing implies that you will still control the company that the technology was developed under and ONLY the intellectual property is transferred to the acquirer. A license can be exclusive (1 company) or non-exclusive (you can license ...
-
Titan Medical Appoints Bill Fahey as Vice President, Manufacturing and Operations
TORONTO, June 06, 2022 (GLOBE NEWSWIRE) -- Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device company focused on the development and commercialization of innovative surgical technologies for single access robotic-assisted surgery (RAS), today announced the appointment of Bill Fahey as Vice President, Manufacturing and Operations. In this new role, Mr. Fahey will be a key member of the ...
-
Augmedics Begins First-in-Human Clinical Trial of xvision-spine (XVS) Augmented-Reality Surgical Navigation System
Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel. Led by Co-Principal Investigators Dr. Ran Harel and Prof. Yigal Mirovsky, the open label, prospective, single arm, multi-center study will evaluate the safety, performance, accuracy and ...
By Augmedics
-
Dr. Frank Phillips is First in the World to Use Augmented Reality Surgical Guidance in Minimally Invasive Spine Surgery
CHICAGO--(BUSINESS WIRE)--Midwest Orthopaedics at Rush announced today that Dr. Frank Phillips, Professor and Director of the Division of Spine Surgery and the Section of Minimally Invasive Spine Surgery at Rush University Medical Center, completed the first augmented reality (AR) minimally invasive spine surgery. The Augmedics xvision™ Spine System surgical guidance system allows a surgeon ...
By Augmedics
-
Augmedics Announces FDA 510K Clearance and U.S. Launch of xvision, the First Augmented Reality Guidance System for Surgery
Augmedics, a pioneer in augmented reality surgical image guidance, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. launch of its groundbreaking xvision Spine system (XVS), the first AR guidance system to be used in surgery. xvision Spine allows surgeons to visualize the 3D spinal anatomy of a patient during surgery as if they had “x-ray vision,” and ...
By Augmedics
-
Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST). LimiFlex is ...
-
FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its ...
-
Nalu Medical Announces Scientific Presentations at 2021 North American Neuromodulation Society (NANS) Mid-Year Meeting
Nalu Medical, Inc. (“Nalu”), a California-based company that has successfully miniaturized neurostimulation implants for chronic intractable pain management indications, announced that the scientific presentation schedule during the 2021 North American Neuromodulation Society (NANS) Mid-Year Meeting in Orlando, Florida will include three abstract submissions all selected for oral ...
-
Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to market in the US. The ...
-
FDA clears nView medical’s first imaging system - nView s1
nView medical Inc. (nView) today announced the U.S. Food and Drug Administration (FDA) clearance of nView s1, the company’s first imaging system, bringing breakthrough imaging technology to surgery. nView’s mission is to make surgery safer, faster, and consistently accurate by creating instant 3D information throughout the surgical procedure. nView s1 integrates the latest ...
-
Cervision™ - First International Sales Launch in Brazil
Spinologics Inc. and Importek have announced today the launch of Cervision™, an upper-extremity patient positioning device for cervical spine surgery, in Brazil. This launch marks the first international sales development of this product since its domestic introduction. “We are pleased to introduce Cervision™ in the Brazilian market”, says Dustin Arless, Director of ...
-
ReShape Lifesciences Announces Appointment of Paul F. Hickey as President and Chief Executive Officer
ReShape Lifesciences™ (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced that its Board of Directors has appointed Paul F. Hickey as President and Chief Executive Officer and as a member of the Board of Directors, effective August 15, 2022. Mr. Hickey succeeds Bart Bandy, who has separated from the company to pursue other ...
Need help finding the right suppliers? Try XPRT Sourcing. Let the XPRTs do the work for you