Regulatory & Legal

Extremities

TriMed Closes Out FDA Warning Letter

Receipt of closeout letter signals the completion of a 24-month initiative to expand and enhance quality management systems.

Business Wire 12.11.19

Sounding Board: Looking Back at 2019 and Gazing at 2020

ODT editorial advisory board members share their thoughts on the most significant events of 2019 and what they expect to watch in 2020.

Online Exclusives Sean Fenske, Editor-in-Chief 12.10.19

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

‘If You’re Reading This, You Need to Be at This Meeting’

The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.

Dawn A. Lissy, President & Founder, Empirical 12.02.19

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

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

Spine/Neurology

South Dakota Spine Surgeon Accused of Kickbacks, Medicare Fraud

Complaint alleges doctor performed procedures with devices in which he had a financial interest.

U.S. Department of Justice 11.15.19

Spine/Neurology

Life Spine Pays $5.5M To Settle Fraud Suit

Life Spine reportedly paid out almost $7M in illicit consulting and licensing fees between 2012 and 2018.

Business Wire 11.11.19

Packaging & Sterilization

Top Surgeons Write a Letter to the FDA

Stress the importance of Ethylene Oxide for medical device sterilization.

AdvaMed 10.25.19

TÜV Rheinland Becomes a Notified Body for the New Medical Device Regulation

New regulation came into effect May 2017.

TÜV Rheinland 10.01.19

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

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

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

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

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

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

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

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

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

Extremities