Regulatory & Legal
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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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Large Joint
FDA Breakthrough Device Designation Given to Active Implants for NUsurface Meniscus Implant
If approved by the FDA, NUsurface would be the first artificial meniscus in the United States.Active Implants LLC 09.19.19
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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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Software & Quality
Benefiting from Paperless Production Records: A Case Study
EpiBone discovered how eliminating paper with digital production records can help ensure data integrity, reduce errors, and increase efficiency.Terrance Holbrook, Director of Product, MasterControl 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
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Spine/Neurology
Straightening Out a Spinal Device’s De Novo Pathway
Intellirod Spine and MCRA collaborated with FDA to take the first spinal device through the de novo pathway.Online Exclusives Sean Fenske, Editor-in-Chief 09.16.19
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Spine/Neurology
Alphatec's CEO Wins Lawsuit Against Former Employer NuVasive
Court ruling extinguishes all non-competition and non-solicitation claims against Pat Miles and Alphatec.GlobeNewswire 08.27.19
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Mayday: How the Upcoming MDR Implementation Forecasts Disaster for Our Industry
I’m generally an optimistic person. My outgoing voicemail greeting encourages every caller to “keep smiling!” My wardrobe is about 40 percent “Life is Good” apparel and I keep a daily gratitude journal. Despite this s…Dawn A. Lissy, President & Founder, Empirical 08.14.19
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Successful Strategies for Health Plan Medical Policy Outreach
Getting approval from the FDA can be a significant achievement for a company but a bigger challenge awaits for novel technologies: health payor acceptance and coverage. Adopting a novel technology does not occur easily due to complex commercial insur…Chelsey Jaworski and Anabel Tapia, MCRA 08.14.19
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Extremities
FH Ortho Receives Japanese Regulatory Clearance for Arrow Prime Anatomic Shoulder System
More than 24,000 cases have been performed worldwide with the Arrow Shoulder System since 2003.Globe Newswire 08.05.19
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Spine/Neurology
Nevro Wins Partial Injunction in Stimwave Patent Suit
Stimwave is barred from infringing patent claims covering frequencies between 3 kHz and 10 kHz by programming SCS systems to deliver new therapy.PR Newswire 07.25.19
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Packaging & Sterilization
Judge Delays Deal Allowing Sterigenics to Reopen Sterilization Facility
Court wants to provide more time for public input.ODT Staff Report 07.25.19
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Packaging & Sterilization
Sterigenics Reaches Agreement with Illinois to Resume Sterilization Operations
Agreement ends all litigation and enforcement actions pending with the state without penalty or finding of fault.Sterigenics 07.18.19
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NICE Guidance Recognizes Better Outcomes With Smith & Nephew's Single-Use NPWT System
Agency recommends the PICO system be considered as an option for closed surgical incisions in patients who are at high risk of surgical site infections.Smith & Nephew plc 07.01.19
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Biologics
The ABCs of HCT/Ps
Navigating the complex regulatory pathway of human cell and tissue products.Lindsay Kleinwaks, Ph.D., Associate, Regulatory Affairs, MCRA 05.23.19
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Design | Software & Quality
Dominating the Competition with Digitization
Companies developing cutting-edge orthopedic devices need cutting-edge technology for their business processes. Whether a company focuses on finding new materials for implants, manufacturing better surgical instruments, or getting a new device throug…Bryant Headley, Customer Success Executive, MasterControl 05.23.19
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Biologics
ISASS Bone Grafting Policy Statement Features i-FACTOR Peptide Enhanced Bone Graft
Society states Cerapedics' drug-device combination technology is shown to be safe and effective as autograft replacement with clinical evidence.Cerapedics 04.29.19
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Software & Quality | Spine/Neurology | Trauma/Sports
Brainlab's Spine & Trauma 3D Navigation Software Recalled Over Misinterpretation Risk
Brainlab is recalling the Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery.U.S. Food and Drug Administration 04.16.19
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Spine/Neurology
Spinal Implant Inspection Practices Established in New Standard
The new standard has broad appeal among different groups involved with surgical implants.ASTM International News 04.09.19
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