Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021

HomeDJO Global Inc.DJO Global, Inc. Announces Clinical Trial for a New Indication for CMF OL1000™ Bone Growth Stimulators

DJO Global, Inc. Announces Clinical Trial for a New Indication for CMF OL1000™ Bone Growth Stimulators


More information on the study can be found here.

DJO Global, Inc. (“DJO Global” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, announces the onset of a clinical trial for a new indication of the CMF OL1000 Bone Growth Stimulator.

Combined Magnetic Field (CMF) devices have been on the market since the early 1990s, providing medical professionals with a tool for the noninvasive treatment of an established non-union fracture acquired secondary to trauma, excluding all vertebrae and flat bones. Due to the type of signal technology, CMF devices are prescribed for a treatment time of 30-minutes per day. These battery-powered, FDA-approved medical devices can be used in conjunction with non-magnetic internal or external fixation, over a cast or brace.

DJO Global, through its subsidiary, Encore Medical L.P., initiated the application for an Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA) for a new indication of the CMF technology into the fresh fracture market. The prospective, randomized, double-blinded, controlled, multi-center clinical study will evaluate the use of the CMF OL1000 as a noninvasive adjunctive treatment for closed, unstable ankle fractures that require surgical treatment for stabilization. The FDA-approved study initiated enrollment in January of this year.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

ProSomnus® Sleep Technologies Adds John E. Remmers, MD, to Leadership Team

Dr. John E. Remmers will provide expert medical and strategic guidance on a range of initiatives, including research and development, regulatory clearances, company strategy, medical education, and clinical investigations.

Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.

Christopher Joyce Joins Miach Orthopaedics as VP & CFO

Christopher Joyce has joined as vice president and chief financial officer, and Kevin Sidow has been appointed to the company’s board of directors.

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF

The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

By using this website you agree to accept Medical Device News Magazine Privacy Policy