implant system News
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HipXpert Now Supports DePuy Synthes’ PINNACLE
Surgical Planning Associates, Inc. announces a new HipXpert software release that now includes the addition of DePuy Synthes’ PINNACLE® Acetabular Cup System and the ACTIS®, CORAIL®, SUMMIT®, and TRI-LOCK® Hip Systems to our patient-specific surgery planning and navigation system. HipXpert’s open-platform, 3D surgery planning software now supports more than 20 ...
By HipXpert
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Coming Soon – The next addition to the EMPOWR Platform
EMPOWR Acetabular™ is DJO’s modern, premium, intelligently designed acetabular system featuring advanced fixation technologies, efficient instrumentation, and a feature enabling future dual mobility offering.1 This system – combined with our femoral stem options which all have 12/14 robust micro-threaded trunnions – provides surgeons a comprehensive THA solution for all ...
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CVRx Launches a new Barostim Programmer
MINNEAPOLIS, July 12, 2022 - CVRx, Inc. (NASDAQ: CVRX) ("CVRx"), developer of the world's first FDA-approved neuromodulation device to treat the symptoms of heart failure, has launched its new Barostim Programmer, which was approved by the U.S. Food and Drug Administration (FDA) earlier this year. The second-generation programmer has a modernized design, operates on an upgraded cellular network ...
By CVRx
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Colibri Heart Valve Strengthens Patent Portfolio with Receipt of 12th Transcatheter Heart Valve (THV) Patent
Colibri Heart Valve LLC, a privately held emerging medical device company, has received an Issue Notification from the U.S. Patent and Trademark Office regarding the forthcoming granting of U.S. Patent No. 9,125,739 (the “’739 Patent”) titled, “Percutaneous Replacement Heart Valve and a Delivery and Implantation System.” This will be Colibri’s 12th ...
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Hyalex Welcomes Chris Cain as VP of Clinical and Regulatory Affairs
Hyalex welcomes executive team member, Chris Cain, serving as Vice President of Clinical and Regulatory Affairs. Chris joins the Hyalex team with an impressive background in leading numerous clinical trials of implanted medical devices and taking innovative technologies through US PMA and international regulatory approvals. Chris provides the experience necessary to bring the HYALEX® ...
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Mainstay Medical Announces Appointment of Jeffrey Dunn and Eric Major to its Board of Directors
DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc today announced the appointment of two new independent members to the company’s board of directors, Jeffrey Dunn and Eric Major. These appointments bring Mainstay’s total board membership to seven. “We are pleased to welcome these two transformational business leaders as new independent directors on the ...
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Centric Medical Announces New Release of Sterile-Packed Rogue+™ Hammertoe Correction System Implants
Centric Medical, the Foot & Ankle division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced today the release of the ROGUE+ Hammertoe Correction System. This sterile-packed innovative system adds to the original implant design also available, while providing internal fixation via a dual threaded construct which is ...
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Ascensia Diabetes Care Announces Fda Approval Of The Eversense E3 Continuous Glucose Monitoring System For Use For Up To Six Months
Ascensia Diabetes Care, a global diabetes company, announces that its partner Senseonics has received approval from the U.S. Food and Drug Administration (FDA) of the next-generation Eversense® E3 continuous glucose monitoring (CGM) System. Ascensia plans to make the E3 sensor, which can be used for up to six months, available to patients in the U.S. during the second quarter of 2022. Robert ...
By Senseonics
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Shoulder Innovations Announces FDA Clearance of New InSet Stemless Humeral Implant
GRAND RAPIDS, Mich., March 14, 2022—Shoulder Innovations LLC., (SI), a leading innovator in the development of shoulder replacement systems, announces the FDA Clearance of their latest component of the InSetTM Total Shoulder System, the InSetTM Stemless Humeral System. The InSetTM Stemless implant is the latest addition to the innovative and integrated InSetTM system, which already includes ...
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SIGNUS and eCential Robotics announce long-term partnership offering an optimized solution combining navigation, robotics and implant systems for spine surgeries
Gières (Grenoble), France, and Alzenau, Germany, September, 28 2021 – eCential Robotics, a French growth company that designs, manufactures, and markets the first unified 2D/3D robotic imaging and surgical navigation system for bone surgery indications, and SIGNUS, an international and family-run company based in Germany that has been the experienced specialist for comprehensive ...
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IlluminOss Medical Receives FDA Clearance for Use in Femur and Tibia Fractures as a Supplement to Approved Hardware
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced an expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System. The new clearance allows IlluminOss to be used in femur and tibia fractures as supplemental fixation to FDA-cleared fracture fixation systems. “Femur and ...
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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 ...
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Nanovis Announces Alpha Launch of the First and Only Bioceramic Nanotube-Enhanced Pedicle Screw System, Nano FortiFix
First use of a nanotechnology enhanced pedicle screw with label claims to increase and accelerate human osteoblast and mesenchymal stem cell calcified extracellular matrix production in vitro CARMEL, Ind., Sept. 28, 2021 - Nanovis, an award winning technology company with unique and differentiated nanotechnology surfaces for improving bone growth and fighting infection, is pleased to announce ...
By Nanovis
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Mainstay Medical Announces Limited Commercial Launch of ReActiv8 in the U.S.
Dublin – Ireland, 29 June 2021 – Mainstay Medical Holdings plc (the “Company”) today announced the limited commercial launch in the U.S. of ReActiv8, its implantable Restorative Neurostimulation™ system to treat intractable chronic low back pain. The ReActiv8 system will be available in the U.S. through ReActiv8-certified physicians commencing in the summer of ...
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Intersect ENT Announces Launch of the New Straight Delivery System Packaged with the PROPEL Mini Sinus Implant
Intersect ENT®, Inc. (Nasdaq: XENT), a global ear, nose and throat (“ENT”) medical technology leader dedicated to transforming patient care, today announced the U.S. availability of the new Straight Delivery System (“SDS”) packaged with the company’s PROPEL® Mini (mometasone furoate) Sinus Implant. The combined packaging of the SDS with PROPEL Mini received ...
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IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures
IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received expanded U.S. Food and Drug Administration (FDA 510k) clearance for its Photodynamic Bone Stabilization System for treatment of fractures of the fibula. The IlluminOss System is a minimally invasive approach for fracture repair and stabilization through a ...
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HealthpointCapital Acquires Majority Stake in IlluminOss Medical, Inc.
HealthpointCapital, the leading private equity firm focused exclusively on musculoskeletal healthcare, today announced the acquisition of a majority stake in IlluminOss Medical, Inc. ("IlluminOss" or the "Company"). IlluminOss offers a unique and disruptive technology for the orthopedic trauma market. The Company's Photodynamic Bone Stabilization System is a minimally invasive approach for ...
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JenaValve Announces First European Commercial Implants with the Trilogy™ Heart Valve System
JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the first commercial implants with the Trilogy Heart Valve System in Europe. The procedures, which included treatment of both aortic regurgitation1 (AR) and aortic stenosis1 (AS), took place in multiple centers in Germany, marks the official start of the ...
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Hyalex receives FDA Breakthrough Device Designation for novel HYALEX Cartilage System
Hyalex Orthopaedics, Inc., announced that the HYALEX Cartilage System has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The HYALEX Cartilage System is intended to repair cartilage defects and restore function for patients with loss of knee articular cartilage and bone requiring surgery. Hyalex is currently in the pre-clinical stage of development ...
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Flowonix Receives FDA Approval for Software Upgrade Designed to Improve User Experience
Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Flowonix Maestro™ Software for Clinician Programmers used to program Prometra® Pump Systems. The new software is designed to improve the user experience for both clinicians and patients. Flowonix expects to begin introducing the new software to customers and implementing the ...
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