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Pure Packs: A Discussion of Ortho Device Packaging & Sterilization
Orthopedic Instrument Manufacturers Are Developing Surgical Support
Looking Over the Shoulder Replacement Market
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Anika Releases Q4 and Year-End 2023 Financial Results
SetPoint Medical Awarded FDA Breakthrough Nod to Treat Multiple Sclerosis
PolarisAR Completes First Procedure with Stellar Knee
FDA Grants Breakthrough Device Designation to Bioretec's Interbody Cage
ODT's Most-Read Stories This Week—March 16
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PolarisAR Completes First Procedure with Stellar Knee
FDA Grants Breakthrough Device Designation to Bioretec's Interbody Cage
Ventris Medical Gains 510(k) Clearance for Amplify Bone Graft Putty
EPA Announces Final Rule to Reduce EtO Emissions
Changes Involving Biocompatibility Testing for Medical Devices—An Orthopedic Innovators Q&A
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Designing for Terminal Sterilization Versus Re-Sterilization
Best Preparation Practices for Medical Emergencies in Orthopedic Manufacturing Facilities
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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
Biologics
Ventris Medical Gains 510(k) Clearance for Amplify Bone Graft Putty
The putty can be used alone or in combination with autograft bone as a bone graft extender.
Sean Fenske, Editor-in-Chief
03.15.24
Biocompatibility & Testing
Changes Involving Biocompatibility Testing for Medical Devices—An Orthopedic Innovators Q&A
Shifting requirements from both the FDA and in the EU have generated significant questions around the laboratory evaluation of devices.
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
Best Preparation Practices for Medical Emergencies in Orthopedic Manufacturing Facilities
Planning and preparation actions companies can take in case of an in-facility accident.
Online Exclusives
Amanda Winstead, Freelance Writer
03.06.24
Spine/Neurology
Nalu Medical Closes $85M Series E Round
Nalu Medical has closed an incremental $20 million in equity financing.
Sam Brusco, Associate Editor
03.05.24
Spine/Neurology
Mainstay Medical Receives $125M Equity Financing
The company plans to use the proceeds to support its continued commercial growth of ReActiv8 restorative neurostimulation for chronic low back pain.
Sam Brusco, Associate Editor
02.27.24
Intuitive Modern Medical Solutions to Distribute Lazurite ArthroFree System
ArthroFree Wireless Camera System will be available throughout New York State except New York City.
Rachel Klemovitch, Assistant Editor
02.22.24
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
Imaging
Pixee Medical Raises $15M for U.S. Expansion, Next-Gen Products
The augmented navigation tech company plans to open a U.S. subsidiary in Q1 2024.
Sam Brusco, Associate Editor
02.08.24
Intro to Due Process for Orthopedic/Medical Product Makers
Delving into critical aspects of the expected processes for medical product manufacturing lifecycle management.
Meredith P. Vanderbilt JD, RAC, CQA, MSE, BSE, Director of Consulting, Empirical
02.05.24
MIS/Robotics
Integrated Endoscopy, Frii Medical Partner to Market Wireless, Single-Use Shaver System
System comes with reusable and rechargeable battery, is designed for endoscopes for arthroscopic surgeries.
Rachel Klemovitch, Assistant Editor
01.25.24
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
Trauma/Sports
IlluminOss Medical Light-Cured Implants Used in 10,000 Surgeries
Surgeons use implants to heal geriatric fractures and strengthen fragile bone.
Rachel Klemovitch, Assistant Editor
01.25.24
Extremities
Voom Medical Devices Introduces Next-Gen Patented Screw
The Revcon Minimally Invasive Screw System features patented screws tailored specifically for minimally invasive bunion treatment.
Michael Barbella, Managing Editor
01.10.24
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
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
Henry Schein Invests in TriMed, Inks Deal with Extremity Medical
Both companies are focused on the orthopedic extremities market.
Sam Brusco, Associate Editor
12.20.23
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
Contract Manufacturing
hg medical to Establish New Manufacturing Facility in Michigan
The company plans to double its organizational capacity.
Charles Sternberg, Associate Editor
12.14.23
Precision Medical Technologies Rebrands
Unveils an updated logo and name.
Charles Sternberg, Associate Editor
12.04.23
Trauma/Sports
IlluminOss Medical Offers Minimally Invasive Approach for Fracture Repair & Stabilization
Helps patients regain mobility faster and resume their daily living activities quicker than conventional implants.
Charles Sternberg, Associate Editor
11.16.23
Retail Healthcare Disruptors and Orthopedic Medical Devices
Many retail healthcare clinics are growing services to include fundamental chronic care management services, pharmacies, and healthy foods.
Maria Shepherd, President and Founder, Medi-Vantage
11.13.23
Biocompatibility & Testing
Updates to Conducting Toxicological Risk Assessment of Medical Device Constituents
A description of new terms and their use in the toxicological risk assessment paradigm of medical device constituents.
Sharlee L. More, Ph.D., DABT, Associate Director, Toxicology, Regulatory Affairs, MCRA LLC
11.13.23
OrthoPediatrics, Ora Medical Sign Distribution Agreement
Orthopediatrics will sell Ora Medical’s gait trainer, The Levity.
Michael Barbella, Managing Editor
11.07.23
Contract Manufacturing
AMETEK to Purchase Paragon Medical for ~$2 Billion
Paragon Medical serves applications including orthopedics, minimally invasive surgery, robotic surgery, and drug delivery.
Sam Brusco, Associate Editor
10.31.23
U.S. Patent Awarded to Biomedical Bonding for Primer Composition
The primer is part of the Swedish firm's bone fracture fixation technology.
Michael Barbella, Managing Editor
10.26.23
Spine/Neurology
Aspen Medical Launches VRTX Spinal Support System
Is designed to redefine spinal care in acute care settings.
Charles Sternberg, Associate Editor
10.25.23
Lazurite Adds Benchmark Medical as a Distributor for its ArthroFree Wireless Camera System
Benchmark specializes in sales to hospitals, surgeons, and ambulatory surgery centers (ASCs) with a focus on orthopedics.
Charles Sternberg, Associate Editor
09.29.23
Spine/Neurology
FDA Clears 4WEB Medical's New Integrated Cervical Plate
The Cervical Spine Truss System Integrated Plating Solution provides an additional stand-alone treatment option for customers.
Michael Barbella, Managing Editor
09.28.23
Spine/Neurology
Saluda Medical's Evoke Spinal Cord Stimulation OK'ed for MRI Scans
The approval offers patients implanted with Evoke the ability to undergo 1.5 or 3T head and extremity and 1.5T full-body MRI scans.
Sam Brusco, Associate Editor
09.26.23
Paragon Medical Accepts $145,600 Workforce Training Grant
Will enhance the skills of its workforce through dedicated Lean Manufacturing and Six Sigma training.
Charles Sternberg, Associate Editor
09.26.23
Paragon Medical Acquires Whimet Inc.
Further strengthens Paragon Medical’s manufacturing capabilities, enabling it to better serve its OEM client base.
Charles Sternberg, Associate Editor
09.19.23
Bioretec and Spartan Medical Enter Agreement for RemeOs Screws
The RemeOs screws received FDA market authorization in March 2023.
Rachel Klemovitch, Assistant Editor
09.13.23
Paragon Medical Acquires Industrial Anodizing
The acquisition increases Paragon Medical’s ability to offer a wide range of manufacturing capabilities.
Rachel Klemovitch, Assistant Editor
09.13.23
The Medical Device Industry's Most Powerful M&A Drivers
For the most part, M&A is driven by large strategic companies and private equity organizations.
Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors
09.12.23
Design
|
Research & Development
How In Silico Simulations Can Slash Medical Device Development Risk
In silico simulations can lower risk-associated device incidents, failures, and recalls.
Muhammad Jamil, Ph.D., Computational Fluid Dynamics Engineer, StarFish Medical
09.12.23
Extremities
Forma Medical Launches MIS Hammertoe Arthrodesis Procedure
OptimalHT received FDA approval in July.
Michael Barbella, Managing Editor
09.06.23
Extremities
|
Spine/Neurology
Globus Medical, NuVasive Close Merger Deal
The deal, which underwent FTC scrutiny, began in February 2023.
Sam Brusco, Associate Editor
09.01.23
Trauma/Sports
Marrow Access Technologies Partners with Spartan Medical
Will provide novel cartilage repair therapy to U.S. veterans and Department of Defense Service Members.
Charles Sternberg, Associate Editor
08.30.23
Vertos Medical Secures $26 Million in Series C Funding
Money will be used to expand the company's commercialization efforts and develop breakthrough treatments for chronic low back pain.
Michael Barbella, Managing Editor
08.30.23
Spine/Neurology
Mainstay Medical Finishes Enrollment in RESTORE Trial for Low Back Pain
Trial expected to validate effectiveness of ReActiv8 restorative neurostimulation vs. optimal medical management for low back pain.
Sam Brusco, Associate Editor
08.29.23
Nalu Medical Begins Enrollment in Peripheral Nerve Stimulation Trial
Nalu PNS system incorporates a battery-free, micro implantable pulse generator, powered by an externally worn device housing the battery and controller.
Michael Barbella, Managing Editor
08.28.23
Spine/Neurology
4WEB Medical Releases Cervical Spine Plating Solution
4WEB plans to expand the cervical product offering in early Q4.
Sam Brusco, Associate Editor
08.16.23
Spine/Neurology
Globus Medical Debuts MARVEL Growing Rod System
Device is the company’s first product designed specifically for early onset scoliosis.
Michael Barbella, Managing Editor
08.11.23
Globus Medical Inc.
...
08.04.23
The Link Between Orthopedics and Connected Medical Devices
How to stay ahead of your competition with connected devices and apps.
Maria Shepherd and Mark Gambale, President and Founder, Medi-Vantage; Director of Business Development, Headway
08.04.23
Rivanna Medical Receives Funding of $30.5 Million
Over 39 months, Rivanna will receive funding for Accuro XV.
Rachel Klemovitch
08.01.23
Breaking News
Anika Releases Q4 and Year-End 2023 Financial Results
SetPoint Medical Awarded FDA Breakthrough Nod to Treat Multiple Sclerosis
PolarisAR Completes First Procedure with Stellar Knee
FDA Grants Breakthrough Device Designation to Bioretec's Interbody Cage
ODT's Most-Read Stories This Week—March 16
View Breaking News >
CURRENT ISSUE
January/February 2024
Pure Packs: Discussing Ortho Device Packaging & Sterilization
Ortho Instrument Manufacturers Are Developing Surgical Support
Looking Over the Shoulder Replacement Market
View More >