News
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The Fundamentals of Go-To-Market Strategy in Orthopedic Medical Devices
Getting the fundamentals right in go-to-market strategy, especially for disruptive products, is critical to success.Maria Shepherd, President and Founder, Medi-Vantage 08.12.22
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Minding the Gap: How Harmonizing Quality Systems Pays Off
FDA issued a proposed rule to harmonize 21 CFR 820 with ISO 13485, which could save medical device companies $439 to $533 million over a decade.Dawn A. Lissy, Founder & President, Empirical 08.12.22
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Trouble Finding Talent? Three People-Centric Measures to Edge Out Competitors
A growing skills gap is a significant concern for CEOs everywhere. In fact, for the Fortune 500, talent is their biggest worry.Tania de Decker, Managing Director—Global Strategic Accounts, Randstad Enterprise Group 08.12.22
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The Case for Using Historical Control in Clinical Trial Design
Historical control refers to the use of data from past studies to estimate potential response to a placebo or standard care treatment among trial patients.Michael Coladonato and Lucas Tatem, MCRA 08.12.22
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Supply Chain
Orthopedic Device OEMs Recover Rapidly to Face Supply Chain Challenges
ODT's Top Company reports reveal a recovery for orthopedic device makers, but now they face a supply chain crisis.Sean Fenske, Editor-in-Chief 08.12.22
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Dental 3D Printing Market is Expanding 20% Annually
Push to digitize dental services is the main market growth factor.Michael Barbella, Managing Editor 08.12.22
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Spine/Neurology
Study Results Released for Abbott's Concussion Blood Test
Could predict outcomes from brain injury and inform treatment interventions.Sam Brusco, Associate Editor 08.11.22
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Bone Growth Stimulators Market to Top $3B by 2030
An increase in fractures and accidents, as well as the world's aging population, is expected to drive the sector's growth.Michael Barbella, Managing Editor 08.11.22
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Surgalign, RTI Settle Lawsuit Over OEM Biz Sale
The parties amended various agreements, including distribution agreements for spinal implants and biologics.Sam Brusco, Associate Editor 08.10.22
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Spine/Neurology
Zavation Shares Results from In-Vitro and In-Vivo Research Study for its Labyrinth Technology
21 day in-vitro study compared Labyrinth to solid PEEK, porous Titanium, and solid Titanium.Charles Sternberg, Associate Editor 08.10.22
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Materials
Cortland Biomedical Adds Suite of Post-Processing Services & Technologies
The latest services will enable the company to provide its OEM customers with their implantable fabric or device in its final form.Charles Sternberg, Associate Editor 08.10.22
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Extremities
First Patient Enrolls in Sonex Health’s U.S. Clinical Study to Treat Carpal Tunnel Syndrome
Will compare efficacy & safety of traditional mini-open carpal tunnel release and carpal tunnel release using UltraGuideCTR and real-time ultrasound guidance.Charles Sternberg, Associate Editor 08.10.22
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Robust Growth Forecast for Joint Reconstruction Market
Sector expected to top $17 billion in 2026.Michael Barbella, Managing Editor 08.10.22
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NuVasive's Chief Commercial Officer Massimo Calafiore Resigns
Will be departing NuVasive to become the CEO of a privately-held orthopedic technology company.Sam Brusco, Associate Editor 08.10.22
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Trauma/Sports
CONMED Closes Deal for Biorez
Gains bioresorbable BioBrace implant for soft tissue healing.Sam Brusco, Associate Editor 08.10.22
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3-D Printing/Additive Mfg. | Materials
Stratasys to Buy Covestro's 3D Printing Materials Biz for €43M
Stratasys will gain a portfolio of about 60 additive manufacturing materials.Sam Brusco, Associate Editor 08.09.22
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Spine/Neurology
NeuroOne Submits Special 510(k) to FDA for sEEG Electrode
Re-submits application to gain FDA clearance for less than 30 day use.Charles Sternberg, Associate Editor 08.09.22
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3-D Printing/Additive Mfg. | Extremities
Custom 3D-Printed Titanium Lower Jaw Used in First Successful Surgery
Has the shape and weight of the original mandible and is stronger than currently used plates.Sam Brusco, Associate Editor 08.09.22
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Software & Quality
Exactech Unveils exacCoach Message Streams
Connects surgeons and patients throughout the care journey.Sam Brusco, Associate Editor 08.09.22
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Spine/Neurology
AxioMed LLC Submits Module III to FDA for Lumbar Viscoelastic Disc Replacement
Becomes the first and only lumbar viscoelastic total disc replacement company to complete a USA IDE clinical trial.Charles Sternberg, Associate Editor 08.09.22
