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Accelus Adds Two New Members to its Board
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ODT's Most-Read Stories This Week—April 20
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Spine/Neurology
FDA Approves Xstim Spine Fusion Stimulator
The capacitively coupled device emits a low-energy signal to promote bone healing following spinal fusion surgery.
Sam Brusco, Associate Editor
04.16.24
Apple Vision Pro Now Carries Osso Health Training App
Osso VR's immersive, next-generation surgical training experience leverages the power of visionOS.
Michael Barbella, Managing Editor
04.15.24
Coatings/Surface Modification
|
Spine/Neurology
Orthobond's Antibacterial Surface Treatment OK'ed for Spinal Devices
The surface technology is applied during manufacturing before packaging and sterilization.
Sam Brusco, Associate Editor
04.08.24
Accelus Appoints New R&D and Product Management Leaders
Rob German joins the company as VP of research and development and Luke Perkins joins as senior director of product management.
Rachel Klemovitch, Assistant Editor
04.08.24
BellaSeno Appoints New Chief Technology Officer and VP Quality and Regulatory Affairs
Dr. Thomas Lingner joins the company as Chief Technology Officer and Inga Freyert is promoted to VP of Quality and Regulatory Affairs.
Rachel Klemovitch, Assistant Editor
04.08.24
FDA Grants De Novo Approval to Onkos Surgical's Antibacterial-Coated Implants
Bacterial contamination of implants can lead to dangerous, potentially fatal complications.
Michael Barbella, Managing Editor
04.08.24
Extremities
eXeX and AdventHealth Surgery Center Use Apple Vision Pro in Joint Replacement Surgery
This surgery demonstrates eXeX’s vision to innovate and enhance healthcare capabilities by improving surgical outcomes and patient care.
Rachel Klemovitch, Assistant Editor
04.04.24
Extremities
|
Trauma/Sports
Paragon 28 Launches Grappler R3INFORCE Extraosseous Repair
Paragon 28 said the system is highly synergistic with its existing offerings and can use the Grappler knotless sutures.
Sam Brusco, Associate Editor
04.02.24
Biologics
NEOS Cranial LOOP OK'ed for CustomizedBone Use
Cranial LOOP devices are made of biocompatible polymer PEEK-OPTIMA to securely fix bone flaps after craniotomies.
Sam Brusco, Associate Editor
04.02.24
Biologics
FDA Approves First-in-Human Trial for RevBio's Regenerative Bone Adhesive
Study will examine the safety and possible benefit of TETRANITE in replacing metal plates and screws in cranial flap fixation.
Michael Barbella, Managing Editor
03.22.24
Osteal Therapeutics Granted FDA Breakthrough Designation for Joint Infection Therapy
Company's VT-X7 delivers antibiotics directly to the infected joint space and surrounding tissue.
Michael Barbella, Managing Editor
03.21.24
Spine/Neurology
SetPoint Medical Awarded FDA Breakthrough Nod to Treat Multiple Sclerosis
The company hopes to use its novel neuroimmune platform for people with relapsing-remitting multiple sclerosis
Sam Brusco, Associate Editor
03.18.24
Spine/Neurology
FDA Grants Breakthrough Device Designation to Bioretec's Interbody Cage
The company's RemeOs implants are absorbed and replaced by bone, which eliminates the need for removal surgery.
Michael Barbella, Managing Editor
03.18.24
Apple Vision Pro Makes its European OR Debut
Augmented reality headset also used for the first time in the U.K. to perform spinal surgeries.
Michael Barbella, Managing Editor
03.15.24
Large Joint
Intellijoint Surgical Gains Second Device Approval in Japan
The company’s KNEE product provides real-time measurements of surgical cutting guides during TKR.
Sean Fenske, Editor-in-Chief
03.12.24
Spine/Neurology
ONWARD Medical's ARC-BCI Accepted to FDA TAP Program
The company is one of the first brain-computer interface entrants accepted into this program.
Sam Brusco, Associate Editor
03.11.24
Biologics
FDA OKs SurGenTec's Hydrophilic Synthetic Bone Graft
OsteoFlo HydroPutty features a combination of proprietary hydrophilic carriers to absorb fluids.
Sam Brusco, Associate Editor
03.07.24
Instruments
Medtronic Wins FDA Nod for OsteoCool 2.0 Bone Tumor Ablation
OsteoCool 2.0's new design allows the use of four internally cooled probes at the same time.
Sam Brusco, Associate Editor
03.04.24
Spine/Neurology
Nevro's SI Fixation System OK'ed for Use Without Lateral Screw
Nevro1 has been proven to immediately transfix the sacroiliac joint to allow long-term joint fusion.
Sam Brusco, Associate Editor
02.29.24
Spine/Neurology
ONWARD Wins 10th FDA Breakthrough Nod for Brain-Computer Interface
The award gives priority U.S. regulatory review to the company’s ARC-BCI system.
Sam Brusco, Associate Editor
02.29.24
Spine/Neurology
Woven Ortho Gets FDA OK for Larger Ogmend Size
The screw fixation implant is now available for most pedicle screw diameters.
Sam Brusco, Associate Editor
02.29.24
Osso VR Appoints New CEO; Former Leader Moves to New Role
Greg Born was welcomed as the new CEO; co-founder Justin Barad, MD will become chief strategy officer.
Sam Brusco, Associate Editor
02.27.24
Extremities
MOON Shoulder Group Nabs Kappa Delta Ann Doner Vaughn Award
Group honored for determining the effectiveness of physical therapy for patients with atraumatic, symptomatic rotator cuff tears.
Michael Barbella, Managing Editor
02.26.24
Nathaniel A. Dyment Receives 2024 Kappa Delta Young Investigator Award
The assistant professor received the honor for his research on tendon and ligament formation, maintenance and repair.
Michael Barbella, Managing Editor
02.23.24
Zimmer Biomet ROSA Shoulder System Receives FDA Clearance
The system becomes the first-to-market robotic surgical assistant for shoulder arthroplasty.
Rachel Klemovitch, Assistant Editor
02.22.24
Spine/Neurology
Neurosurgeon Kevin Foley Appointed to Curiteva’s Board of Directors
New member is recognized in the industry for helping advance minimally invasive surgery.
Michael Barbella, Managing Editor
02.15.24
Biologics
Bone Solutions' OsteoCrete OK'ed for Intervertebral Body Fusion
According to the company, this is the first, only magnesium-based bone substitute cleared by the FDA for this application.
Sam Brusco, Associate Editor
02.13.24
Jim Kircher Appointed New CEO of Norwood Medical
Kircher succeeds Dr. Frank Stietz, a member of Heraeus Group’s board of managing directors.
Sam Brusco, Associate Editor
02.13.24
Spine/Neurology
Mainstay Medical's ReActiv8 Implant OK'ed for MRIs
The ReActiv8 implant is used to treat adults with intractable chronic low back pain associated with multifidus muscle dysfunction.
Sam Brusco, Associate Editor
02.12.24
Trauma/Sports
FDA OKs Tyber Medical's Proximal Tibia Plating System
The treatment for complete and articular fractures features single and multiple component metallic bone fixation.
Sam Brusco, Associate Editor
02.12.24
Spine/Neurology
Boston Scientific's WaveWriter Spine Stimulators OK'ed for Non-Surgical Back Pain
The expanded FDA indication was supported by positive one-year SOLIS randomized control trial results.
Sam Brusco, Associate Editor
02.06.24
Biologics
|
Spine/Neurology
Aurora Spine Nabs 2nd U.S. Patent for DEXA Patient-Matched Implant Tech
The new patent will be used to create fusion implants that match the patient’s specific bone density.
Sam Brusco, Associate Editor
02.05.24
Spine/Neurology
FDA Approves Theradaptive IDE Phase I/II Clinical Trials
Study to assess efficacy and safety of the company’s OsteoAdapt SP spinal fusion product.
Rachel Klemovitch, Assistant Editor
02.02.24
FDA Clears IlluminOss's New Light Console for Implants
The new light-emitting diode console reduces curing time by up to 50%.
Michael Barbella, Managing Editor
02.01.24
Spine/Neurology
SI-BONE Gets FDA OK for Smaller iFuse Bedrock Granite Implant
The 9.5 mm implant also gained expanded indications for pediatric patients and an application for use in the S1 trajectory.
Sam Brusco, Associate Editor
01.31.24
Extremities
Tyber Wins FDA Nod for Mini-Frag System Line Extension
The Mini-Frag system’s line extension includes 1.3 mm screws and plates, expanding its range of sizes.
Sam Brusco, Associate Editor
01.29.24
Spine/Neurology
Aurora Spine Wins Patent for Translucent GhostTube Surgical Operating Tube
GhostTube supports surgical preparation tools without blocking X-ray visualization during surgery.
Sam Brusco, Associate Editor
01.29.24
Trauma/Sports
FDA OKs Able Medical's Valkyrie RIB for Thoracic Repair
The PEEK-based Valkyrie RIB, according to the company, helps minimize patient stress shielding.
Sam Brusco, Associate Editor
01.25.24
Instruments
|
Large Joint
Enhatch Earns FDA Nod for AI-Powered TKA Patient-Specific Instrumentation
The system features AI algorithms that convert patient X-rays or CT images into detailed, 3D anatomic models
Sam Brusco, Associate Editor
01.24.24
Spine/Neurology
Abbott Wins FDA MRI Labeling Approval for Proclaim DRG
Patients implanted with Proclaim DRG can now receive full-body MRI scans.
Sam Brusco, Associate Editor
01.18.24
Biologics
Robert E. Gagnon Appointed to Bone Biologics Board of Directors
New addition has more than 20 years of experience in finance and business operations at both public and private life sciences companies.
Michael Barbella, Managing Editor
01.12.24
Spine/Neurology
FDA OKs Providence Medical's CAVUX FFS-LX Lumbar Facet Fixation
The fixation system was cleared for 1- and 2-level lumbar spinal fusions.
Sam Brusco, Associate Editor
01.10.24
Cerapedics Files Final Module in PMA Application for P-15 Bone Graft
Gets closer to introducing its P-15 Peptide Enhanced Bone Graft to the large population of patients undergoing TLIF procedures in the U.S.
Charles Sternberg, Associate Editor
01.05.24
Extremities
|
Instruments
Paragon 28 Rolls Out Grappler Knotless Anchor System & Bridgeline Tape
The devices can be used in foot and ankle soft tissue procedures.
Sam Brusco, Associate Editor
01.05.24
Biologics
CGBio Nets FDA Breakthrough Nod for Novosis Putty
Novosis putty is an advanced bone substitute material that incorporates recombinant bone morphogenetic protein 2 (rhBMP-2).
Sam Brusco, Associate Editor
01.03.24
Spine/Neurology
ulrich medical USA Grabs Expanded Indication for Momentum Systems
Momentum and Momentum MIS posterior spinal fixation systems can now be used with G21 V-STEADY radiopaque bone cement.
Sam Brusco, Associate Editor
12.21.23
Extremities
|
Trauma/Sports
Tyber Medical's Distal Radius Plates Gain FDA Nod
The plates maintain stability and orientation in the anteroposterior plane using a dynamic grouping of plate length options.
Sam Brusco, Associate Editor
12.18.23
ZimVie's Vital Spinal Fixation System Compatible With Brainlab Spine & Trauma Navigation
ZimVie plans to co-market Brainlab Spine & Trauma Navigation alongside its Vital and Virage lines.
Michael Barbella, Managing Editor
12.12.23
Trauma/Sports
OSSIOfiber Scores FDA OK to Fix Bone Fractures in Children
OSSIOfiber compression screws and trimmable fixation nails can now be used in children aged two to 21 in standard clinical practice.
Sam Brusco, Associate Editor
12.06.23
Extremities
|
Imaging
ExactechGPS Ankle Surgical Navigation System Nabs FDA Nod
The company said GPS Ankle is the world’s first surgical navigation system for total ankle arthroplasty.
Sam Brusco, Associate Editor
12.06.23
Breaking News
Accelus Adds Two New Members to its Board
First-in-Human Hyalex Knee Cartilage Treatments Completed
Exactech Gains Patents for Soft Tissue Balancing Technology
OrthoIndy Performs First Procedure Using Surgical Theater's XR Technology
ODT's Most-Read Stories This Week—April 20
View Breaking News >
CURRENT ISSUE
March/April 2024
Extreme Fixes for Orthopedic Extremity Surgery
Print Shop: Insights on Orthopedic Additive Manufacturing
Molding Is Taking Its Place in Orthopedic Device Manufacturing
A View of Mixed-Reality Tech's Future in Orthopedics
Improving Patient-Specific Outcomes with In-Silico Trials
View More >