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Spine Wave Announces U.S. FDA's 510K Clearance of the StaXx(R) IB System, an Intervertebral Body Fusion Device

April 29, 2013 8:00 am | by The Associated Press | News | Comments

Spine Wave, Inc. a privately held medical device company committed to the development and delivery of high-quality innovative medical devices for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration to...

Remote-Monitored Prostheses

April 26, 2013 2:58 pm | by CTIA | Videos | Comments

Amputees are enjoying an improved quality of life with wireless enabled prostheses. The prosthetic sends data to the care-giver to make better informed adjustments, and the patient can even make adjustments from their mobile phone.      

April 2013 Digital Edition

April 25, 2013 2:45 pm | by MDT Staff | Digital Editions | Comments

Given the number of device applications that involve the transfer of a gas or liquid, it is no wonder pump technology is such a significant part of many healthcare-related products. “Innovation Drives Pump Technology to Meet Today’s Medical Designs” focuses on how today’s medical device demands are being answered by advanced pump technology.

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K2M Grows Biologics Offering with Expansion of VESUVIUS Product Family

April 25, 2013 10:08 am | by K2M | News | Comments

K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced another expansion of the company’s U.S. biologics offering with the addition of a new product line to the VESUVIUS™ Osteobiologic Systems.

Implant Brings High Hopes for Back Pain Relief

April 25, 2013 9:35 am | by ReutersTV | Videos | Comments

A new spinal implant developed in Israel, has radically improved the life of at least one patient who, four years ago, believed he would spend his twilight years in constant pain. Seventy-nine-year-old Moshav farmer Yehuda Schwartz suffered from a debilitating back condition common among senior citizens but says, since receiving the implant, he's been given a new lease on life.

Vycor Adds Two Patents for Its New Spinal ViewSite(TM) Cervical Access System

April 25, 2013 8:33 am | by The Associated Press | News | Comments

Vycor Medical, Inc. announced today it has secured two new patents (2008-518369 and 11/993280) covering its Spinal ViewSite™ Cervical Access System (VCAS). The addition of these patents brings Vycor's total patent portfolio to 34 issued and 21 pending. The Company's...

Meeting Announcement: July 24-25, 2013 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

April 25, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On July 24, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion.  The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device.

Ergoresearch to Acquire Victhom

April 24, 2013 5:21 pm | by PR Newswire | News | Comments

Ergoresearch Ltd. and Victhom Human Bionics Inc. announced today that the Superior Court of Québec has issued a final order approving the previously-announced plan of arrangement relating to the acquisition by Ergoresearch Inc., a direct wholly-owned subsidiary of Ergoresearch, of Victhom.

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Medstrat Posts Documents Confirming Terms Of Dismissal Of Merge's Lawsuit

April 24, 2013 4:53 pm | by PR Newswire | News | Comments

Medstrat, Inc., a leading provider of picture archiving and communications system (PACS) technology to Orthopaedic practices and hospital systems, announced today that it has posted the terms of the Settlement Agreement by which Merge Healthcare dismissed its November 14, 2012 lawsuit filed against Medstrat. 

Consumer Information on: DePuy Ceramax Ceramic Total Hip System - P070026S004

April 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This is a brief overview of information related to FDA’s approval to market this product.  See the links to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

3v07 Medical Advertising Introduces Social Anthropology Product

April 23, 2013 9:17 am | by The Associated Press | News | Comments

LAGUNA BEACH, Calif.--(BUSINESS WIRE)--Apr 23, 2013--Healthcare advertising is seeing more medical device companies going direct to consumers thanks to the effectiveness of the Internet in reaching people looking for answers online to their medical conditions. This has made it important for...

Meeting the FDA’s Mandates for Unique Device Identification

April 22, 2013 2:22 pm | by Hiroshi Ono, Group Product Manager, Roland DGA Corp. | Roland DGA Corporation | Articles | Comments

The FDA’s UDI rule is on its way and will impact virtually everyone in the industry in one way or another. While the rule has its benefits, getting to compliance will not be achieved overnight. This article provides an overview of the direct part marking technologies required to comply with the UDI rule and offers a solution that addresses the shortcomings of several other technologies.

Healthcare's First Direct Contracting Market Launches Today; Will Offer Mutually Beneficial Approach for Hospitals and Suppliers

April 22, 2013 9:00 am | by PR Newswire | News | Comments

IRVING, Texas, April 22, 2013 /PRNewswire/ -- Today aptitude announced the launch of the healthcare industry's first online direct contracting market, a one-stop destination designed to complement a hospital's existing contracting model or provide an alternative for those looking...

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Foundation Venture Capital Group Invests In Company Developing Implantable Meniscus for Knee Repair

April 18, 2013 2:13 pm | by Bio-Medicine.Org | News | Comments

Newly formed NovoPedics, Inc., has received a commitment of up to $500,000 from Foundation Venture Capital Group to advance its development of an implantable meniscus replacement/regeneration medical device. Currently in the United States, the treatment options for pain after meniscectomy are limited to replacement with allograft (cadaver) tissue, bone realignment surgeries and knee replacement surgery...

Class I Medical Device Recall: Stryker Orthopaedics - ShapeMatch Cutting Guide

April 18, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Stryker Orthopaedics has become aware of potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via the web application.

Johnson & Johnson Lands Jury's Favor in Second Metal-on-Metal Hip Lawsuit

April 17, 2013 12:16 pm | by Mass Device | News | Comments

A Chicago jury this week jury ruled in favor of healthcare giant Johnson & Johnson (NYSE:JNJ), rejecting a patient's claims that the company was liable for injuries she allegedly sustained after receiving the metal-on-metal ASR XL hip implant. Legal News,

Global Medical Robotic Systems Market is Expected to Reach USD 13.64 Billion by 2018: Transparency Market Research

April 17, 2013 6:30 am | by PR Newswire | News | Comments

ALBANY, New York, April 17, 2013 /PRNewswire/ -- According to a new market report published by Transparency Market Research (http://www.transparencymarketresearch.com) "Medical Robotic Systems Market (Surgical Robots, Non-Invasive Radiosurgery Robotic Systems, Prosthetics and...

Medical Designs, LLC Announces the National Marketing Launch of the FDA-Approved SAMBA™ Screw System, a Minimally Invasive Solution for the Treatment of SI-Joint Dysfunction

April 17, 2013 1:31 am | by The Associated Press | News | Comments

SIOUX FALLS, S.D.--(BUSINESS WIRE)--Apr 17, 2013--Medical Designs, LLC, a pioneer in the development of minimally invasive spinal implants, announced today the national marketing launch of the FDA-approved SAMBA™ Screw System, a minimally invasive solution for the treatment of SI-Joint...

Layoffs ahead for Medtronic's spinal business

April 15, 2013 2:18 pm | by Mass Device | News | Comments

Medical device company Medtronic confirmed today that there are layoffs ahead for its spinal business, affecting an undisclosed number of workers at various locations. The medtech titan doesn't plan to release details until next month, but rumors are already swirling that a Warsaw, Ind., spinal facility may lose as many as 50 workers.

Fixes 4 Kids Inc. Relocates Medical Device Manufacturing Operations to North Dakota

April 15, 2013 8:15 am | by The Associated Press | News | Comments

FARGO, N.D.--(BUSINESS WIRE)--Apr 15, 2013--Fixes 4 Kids, Inc. today announced that it has relocated its manufacturing operations to North Dakota. Working with Wahpeton-based ComDel Innovation (CDI), the company is focused on bringing economic development, infrastructure and technological...

New Study Supports Titan Spine Endoskeleton® Interbody Device for Rapid Fusion and Improved Patient Outcomes

April 15, 2013 8:02 am | by The Associated Press | News | Comments

MEQUON, Wis.--(BUSINESS WIRE)--Apr 15, 2013--Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, announced today that clinical data support the use of its Endoskeleton ® titanium interbody cage for achieving rapid lumbar...

Wright, Biomet, Stryker Hip Recall Settlement Funding News: Legal-Bay To Increase Funding Amounts Up to $50K

April 15, 2013 5:00 am | by PR Newswire | News | Comments

Legal-Bay LLC announced today that they have increased their funding amounts to $50K on a select few Stryker Hip recall cases for clients waiting for their settlement check. Legal-Bay has been an industry leader in Stryker hip implant recall cases needing lawsuit funding –and all harmful product liability cases involving hip and knee products. 

ORTHOWORLD(R) Announces FDA Official to Serve as Panelist at Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC(R))

April 12, 2013 9:52 am | by PR Newswire | News | Comments

CHAGRIN FALLS, Ohio, April 12, 2013 /PRNewswire/ -- ORTHOWORLD, Inc., leading producer of strategic intelligence for the orthopaedic industry, announced its education curriculum for OMTEC 2013, to be held June 12-13 in Chicago. OMTEC's keynote panel discussion, The State and Future of...

NuVasive(R) to Exhibit Innovative Products and Procedures at AANS 2013

April 11, 2013 8:30 am | by The Associated Press | News | Comments

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce their participation at the 81st American Association of Neurological Surgeons (AANS) Scientific Meeting from Saturday,...

Forum Tackles the Rising Costs, Challenges and Diminished Outcomes Associated with Treating Obese Patients for Orthopaedic Conditions

April 10, 2013 3:00 pm | by PR Newswire | News | Comments

The obesity epidemic in America and its impact on musculoskeletal health, as well as related treatment outcomes and costs, was discussed during the AAOS Now forum, "Obesity, Orthopaedics and Outcomes," at the 2013 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) at McCormick Place in Chicago.

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