Regulatory & Legal

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

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

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

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

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

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

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

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

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

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

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

ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?

ISO 14971 for medical device risk management is in the final stages of an important update slated for publication this year. While ISO has specifically said the intent of the revision isn’t to rework the risk management process, subtle changes…

Tony Parise, Product Strategist—Life Sciences, ETQ 03.29.19

Design

Regulatory Perspectives: Anatomy of a Medical Policy

Health insurance is a contract between a third party payer (insurer) and an individual to help cover medical and surgical expenses. The insured party pays a premium to the health insurer for this benefit. The rights and obligations of the insured and…

Bonnie Clothier and Simran Madhani, MCRA 03.29.19

FDA Commissioner Scott Gottlieb to Step Down

The 46-year-old physician, former venture capitalist, and drug consultant is due to resign in a month.

Sam Brusco, Associate Editor 03.05.19

Spine/Neurology

FDA Issues Guidance on Brain-Computer Interfaces for Paralysis or Amputee Patients

These devices can allow significantly greater mobility and independence for patients.

Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 02.25.19

Spine/Neurology

Stimwave Responds to Nevro Patent Lawsuit

Stimwave maintains that the claims in the lawsuit are completely baseless, unfounded, and invalid.

Business Wire 02.22.19

Spine/Neurology

Nevro Files U.S. Patent Lawsuit Against Stimwave

Nevro asserts Stimwave is infringing patent's covering the Senza system and HF10 therapy.

PR Newswire 02.15.19

An Industry on the Defensive

It’s been a rough six months for the medtech industry. Nearly 200 days after it was first blindsided by a one-two punch of bad publicity from the damning Netflix documentary “The Bleeding Edge,” the sector remains firmly immersed…

Michael Barbella, Managing Editor 02.13.19

Design | Research & Development

Trial Master File: Paper or Electronic?

The Trial Master File (TMF) is the central location for all clinical trial documents. From the start of a clinical trial through its conclusion, the TMF contains and secures a variety of information such as signature pages, study logs, ethics committ…

Anuradha Nagulapati, Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers 02.13.19