International
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Bracing/Prosthetics
Orthotics Breakthrough Helps Children with Cerebral Palsy Walk and Play
Can decrease the energy they use to walk by as much as 33 percent.Staffordshire University 06.10.20
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Spine/Neurology
Nevro Earns CE Mark for Senza Omnia Spinal Cord Stimulation
Designed to provide physicians maximum versatility to manage chronic pain.PR Newswire 05.14.20
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MDR Delay Official; Industry Urges Push Back of IVDR
European Council voted 27-0 to adopt amendment delaying MDR application by one year due to COVID-19 pandemic.MedTech Europe 04.24.20
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Biologics
Biocomposites' STIMULAN Earns CE Mark
First calcium matrix to receive European approval as an antibiotic carrier for use in bone and soft tissue.PR Newswire 04.23.20
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Spine/Neurology
'Smart' Chair Will Correct Students' Posture
The chair is equipped with special sensors that detect posture and forewarn when people are sitting incorrectly.South Ural State University 01.17.20
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3-D Printing/Additive Mfg. | Biocompatibility & Testing
LimaCorporate Opens 3D Printing Center & Advanced Laboratory for Testing and Analysis
Both will strengthen the collaboration between all departments and surgeons.PR Newswire 01.17.20
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Bracing/Prosthetics
First 3D-Printed, Sensor-Operated Prosthetic Arm for Toddlers
UK team built a prototype of a myoelectric (muscle-stimulated) prosthesis for children under two.University of Lincoln 01.14.20
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Trauma/Sports
Silver Bullet's Antimicrobial Bone Screw Wins CE Mark
OrthoFuzIon Orthopedic Bone Screw System is the world’s first regulatory-approved antimicrobial bone screw product for orthopedic procedures.Business Wire 01.10.20
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MIS/Robotics | Packaging & Sterilization
Anxious Undertones: A Review of 2019
Despite a healthy U.S. economy and solid corporate growth, the medtech industry was wracked with worries in 2019.Michael Barbella, Managing Editor 12.02.19
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Turning the New EU MDR Into a Competitive Advantage
This column examines three new elements of the EU MDR that medical device manufacturers can leverage.Dan Goldstein, Associate Director, Quality Assurance, MCRA LLC 12.02.19
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Getting a Jump on 2020: Orthopedic Industry's 'To-Do' List
Are device tax, MDR, bundled payments, and value-based healthcare focal points for you and your company as we round out the year?Sean Fenske, Editor-in-Chief 12.02.19
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Large Joint
mediCAD is Now Officially a Medical Device in Japan
The product is an orthopedic planning solution for hip, knee, shoulder, hand, leg, or spine surgery.mediCAD Hectec GmbH 12.02.19
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Large Joint
World’s First 'Artificial Meniscus' Available in Israel
Two patients receive NUsurface implant from Active Implants.Active Implants LLC 11.19.19
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Materials | Trauma/Sports
The Screw That Dissolves
Researchers analyze biodegradable magnesium orthopedic screws.Empa, Swiss Federal Laboratories for Materials Science and Technology 11.06.19
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Compamed 2019 Preview Report
Experience the full range of supplier expertise for the medical technology industry.Online Exclusives Klaus Jopp 10.08.19
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TÜV Rheinland Becomes a Notified Body for the New Medical Device Regulation
New regulation came into effect May 2017.TÜV Rheinland 10.01.19
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3-D Printing/Additive Mfg. | Spine/Neurology
Kanfit3D Enters Joint Research Venture with Brescia University
Project to develop special surface parameters for Ti64 implants.Kanfit3D 09.25.19
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U.S. May Offer a Safe Harbor from the Impending MDR Storm
There are factors that make for a more inviting environment for the medical device industry in the United States.Dawn A. Lissy, President & Founder, Empirical 09.17.19
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How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations
As of 2017, the European medical device market was estimated at $126 billion, the second largest worldwide, comprising 27 percent of the global market. The European market trails only the United States, which accounts for roughly 43 percent of…Mike Goodson, Associate Director, Regulatory Affairs, MCRA LLC 09.17.19
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An MDR Roundup
Anyone involved in medical device development and manufacture has undoubtedly heard of the regulatory changes happening in the EU beginning May 2020, lest they have been living under the proverbial rock. So much has been written and discussed, in fac…Sean Fenske, Editor-in-Chief 09.17.19
