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Congress Tackles LDT Regulation: FDA Authority and Adverse Events

September 15, 2014 10:27 am | by Richard Park, Contributing Editor | Blogs | Comments

Last week, the House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing on FDA’s notification to Congress at the end of July that it intends to issue draft guidance on a framework for oversight of laboratory...

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Medtronic Launches SEEQ Wearable Cardiac Monitoring System in United States

September 15, 2014 10:18 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the U.S. launch of the SEEQ Mobile Cardiac Telemetry (MCT) System, an external, wire-free, adhesive heart monitor that can be worn for up to 30 days to help detect and diagnose the cause of irregular heartbeats in...

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Medtronic’s CoreValve System Sustains Positive Outcomes Through Two Years in Extreme Risk Patients

September 15, 2014 10:14 am | by Medtronic | News | Comments

Medtronic, Inc. has announced new data showing that transcatheter aortic valve replacement (TAVR) with the CoreValve System continued to provide safe and effective treatment, while maintaining exceptional rates of survival out to two years for...

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Toughening Up Hydrogels for 3D-Printed Cartilage

September 15, 2014 10:11 am | by University of Wollongong | News | Comments

Thanks to their composition (mostly water), hydrogels hold much promise for use in medical bionic applications, their softness being more readily acceptable to the body than hard materials. However, despite naturally occurring hydrogels (like...

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Researchers Take Up Challenge of Reviving Cartilage

September 15, 2014 10:03 am | by Stanford | News | Comments

Constance Chu was a medical student observing a surgery performed by her teacher when she caught her first glimpse of human articular cartilage, the smooth, glistening coating that covers the ends of bones as they meet at the ankle, knee and...

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Quantel Medical's Vitra PDT Laser Receives CE Mark Approval

September 15, 2014 9:48 am | by PR Newswire | News | Comments

Quantel Medical today announced CE Mark approval for its Vitra PDT photodynamic therapy laser platform, for the treatment of polypoidal choroidal vasculopathy (PCV) and central serous retinopathy (CSR). Quantel, the sole manufacturer of this...

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Significant Patient Benefits With Edwards Sapien Valve Demonstrated

September 15, 2014 9:47 am | by PR Newswire | News | Comments

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced the presentation of five-year clinical outcomes for inoperable patients treated in The PARTNER Trial, the world's...

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12-Month Data from St. Jude's Renal Denervation System Show Continued Safety and Efficacy

September 15, 2014 9:46 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced 12-month outcome data from the EnligHTN III study, which demonstrated a continuation of safe, rapid and effective treatment with the next-generation EnligHTN Renal Denervation...

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Venezuela's Newest Shortage: Breast Implants

September 15, 2014 9:44 am | by Hannah Dreier, Associated Press | News | Comments

Venezuela's chronic shortages have begun to encroach on a cultural cornerstone: the boob job. Beauty-obsessed Venezuelans face a scarcity of brand-name breast implants, and women are so desperate that they and their doctors are turning to devices...

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FDA Approves New Styles Of The MENTOR MemoryShape Silicone Breast Implant

September 15, 2014 9:41 am | by The Associated Press | News | Comments

Mentor Worldwide LLC, the U.S. market leader in breast aesthetics, today announced the U.S. Food and Drug Administration (FDA) has approved four additional styles of the MENTOR MemoryShape Breast Implants, expanding its suite of silicone breast...

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Philips Showcases Ultrasound Innovations that Address Clinical Challenges in the OB/GYN Segment

September 15, 2014 9:39 am | by The Associated Press | News | Comments

Royal Philips has announced that its growing range of advanced women's healthcare imaging solutions will be showcased at the 24th annual International Society for Ultrasound in Obstetrics and Gynecology (ISUOG) World Congress, taking place...

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St. Jude Medical Announces Launch of OPTIS Integrated System

September 15, 2014 9:38 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the company has secured CE Mark and FDA clearance for the new OPTIS Integrated System. The system is a departure from traditional, mobile cart-based diagnostic tools...

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3D Systems Introduces New Simbionix Virtual Reality Surgical Simulation Training Module

September 15, 2014 9:30 am | by PR Newswire | News | Comments

3D Systems announced today the addition of a new Simbionix ultrasound training module for the practice of transvaginal ultrasound exams (GYN TVS) at the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) exhibition in...

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Don't Patent Too Soon: Look at the Market

September 15, 2014 8:30 am | by Stephen Knowles, Managing Director, Industrial Design Consultancy (IDC) | Blogs | Comments

The first step in new product development is to qualify the market for the idea, before doing anything else. Potential developers need to ask the questions: Does the device solve a clinical need? How will it enhance outcomes and save...

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Addition of 3D Printing Services

September 15, 2014 8:30 am | by MDT Staff | Crescent Industries, Inc. | Product Releases | Comments

At Crescent Industries 3D printed models have been used to speed up the molding process by using them for design review, quality inspection, product fixtures and end of arm tooling. These 3D components provide beneficial uses at Crescent for the following reasons...

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