The MDR Delay’s Impact on Regulatory and Testing—An Orthopedic Innovators Q&A
While the recent MDR delay gives companies some breathing room, it should not stall their effort in ensuring their products remain compliant for the EU.
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AAOS Comments on Info Request for Episode-Based Payment Model
In a letter, AAOS expressed its support for engaging physicians in designing and implementing alternative payment models.Michael Barbella, Managing Editor 08.25.23
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RevBio Granted ISO 13485 Certification
Company's bone adhesive was tested last year on the International Space Station.Michael Barbella, Managing Editor 08.21.23
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Spine/Neurology
FDA Grants Clearance to CTL Amedica's NITRO Interbody Fusion Cage System
Product's material has unique bacteriostatic properties, provides artifact-free imaging, and is compatible with all imaging modalities.Michael Barbella, Managing Editor 08.15.23
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AAOS Releases New Guidance to Simplify Patient-Reported Outcome Measures in Practice
New interactive, high-quality tools help orthopedic surgeons collect patient data in advance of mandatory reporting periods.Michael Barbella, Managing Editor 08.07.23
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Biologics
Aziyo Biologics Issues Voluntary Recall of Viable Bone Matrix Products
Recall trigged by reports of post-surgical infections in two patients.Michael Barbella, Managing Editor 07.14.23
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AAOS Releases New Appropriate Use Criteria
The guidelines target shoulder osteoarthritis treatment.Michael Barbella, Managing Editor 07.12.23
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Spine/Neurology
NASS Recommends Basivertebral Nerve Ablation as a Low Back Pain Treatment
The policy proactively defines appropriate coverage positions based on the effectiveness of BVN ablation as a treatment option.Michael Barbella, Managing Editor 05.15.23
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Biocompatibility & Testing
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Extremities
Treace Medical, Fusion Ortho Settle IP Lawsuit
The terms of the settlement were not released.Sam Brusco, Associate Editor 03.03.23
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AAOS Updates CPG for Surgical Management of Knee Osteoarthritis
Updated guideline offers the latest in evidence-based research to improve surgical success and reduce complications, postoperative pain.Michael Barbella, Managing Editor 03.01.23
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Conformis, Bodycad Laboratories Settle Patent Litigation
Settlement resolves ongoing dispute that began in June 2021.Michael Barbella, Managing Editor 02.16.23
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3-D Printing/Additive Mfg. | Instruments
Reflections on 2022 and What’s Ahead for Orthopedic Technology: ODT Sounding Board
Several members of the ODT editorial advisory board share their thoughts on the headlines of 2022 and what’s coming in 2023.Online Exclusives Sean Fenske, Editor-in-Chief 12.01.22
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Breast Cancer Survivor Living Near Medical Sterilization Plant Awarded $363M
Sterigenics vows to appeal the decision.Michael Barbella, Managing Editor 09.22.22
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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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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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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
Nevro, Boston Scientific Settle IP Lawsuits
Lets Boston Scientific use the features and capabilities in its current line of products for frequencies below 1,500 Hz.Sam Brusco, Associate Editor 08.01.22
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Bracing/Prosthetics
Orthotic Brace Suppliers Convicted in $6.5M Fraud Scheme
Each defendant faces up to 55 years in prison.Sam Brusco, Associate Editor 05.18.22
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3-D Printing/Additive Mfg.
Testing and Regulatory Landscape for Additively Manufactured Devices—An Orthopedic Innovators Q&A
Uncertainty in proper procedures has left orthopedic device manufacturers seeking answers.
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Extremities
Extremity Medical Files Patent Suit Against Fusion Orthopedics
Company alleges infringement on patent for its intraosseous fixation platformSam Brusco, Associate Editor 04.29.22
