Featured
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3 Critical Considerations for U.S. Medical Device Commercialization
the step-by-step process of working with the FDA to bring a medical device to the U.S.Online Exclusives Michael Lynch, Managing Consultant, Intertek 05.18.18
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Hearing Aid Companies Sivantos and Widex Merge in $8 Billion Deal
The merged company is now a top three contender in the hearing aid market.Sivantos 05.18.18
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Digital Health | Electronics
Mike on Medtech: Voice-Enabled Medtech
Sean Fenske and Mike Drues discuss voice-enabled medtech and its potential in healthcare.Sean Fenske, Editor-in-Chief 05.17.18
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Diagnostics
Modular Blocks Could Enable 'Plug and Play' Diagnostic Devices
Modular blocks could allow labs around the world to cheaply and easily build their own diagnostics.Videos Anne Trafton, MIT News Office
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Cardiovascular | Surgical
Surmodics Acquires Embolitech Thrombectomy Tech for $5 Million
Surmodics’ design, development, hydrophilic coating technology, and manufacturing capabilities will advance the platform.Business Wire 05.14.18
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Materials | Surgical
Boston Scientific Responds to '60 Minutes' Transvaginal Mesh Report
The company released an open letter denying 60 Minutes' claims of using a counterfeit Chinese plastic for its mesh products.Boston Scientific 05.14.18
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Surgical
Dräger Medical Recalls Fabius Anesthesia Machines Due to Production Step Error
The recalled anesthesia machines contain excessive oil not removed during production, which may cause ventilation to fail.U.S. Food and Drug Administration 05.10.18
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FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
Actions part of a comprehensive approach to the oversight of regenerative medicine products.U.S. Food and Drug Administration 05.10.18
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Sirtex Receives $1.4B Counteroffer from Chinese Investment Firm
The Sirtex board of directors has determined to engage with CDH Investments to further understand the conditions.PR Newswire 05.07.18
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Contract Manufacturing | Surgical
Integer to Divest Advanced Surgical and Orthopedics Lines to MedPlast for $600 Million
Move provides Integer financial flexibility; acquisition bolsters MedPlast’s portfolio.Integer Holdings Corporation 05.04.18
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A Services Convergence: A Review of Medtech's Consolidating Supply Chain
A survey of mergers and acquisition activity in the medtech outsourced manufacturing market.Bill Ellerkamp, Contributing Writer 05.03.18
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Contract Manufacturing
Developing the True Partnership: A Full-Service Outsourcing Roundtable
Successful OEMs recognize their top service providers as development partners instead of transactional suppliers.Sean Fenske, Editor-in-Chief 05.03.18
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So Fruitful Together: An M&A Roundtable
M&A is a key component of evolving business strategies that will enable companies to better compete in a value-driven market.Michael Barbella, Managing Editor 05.03.18
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R&D & Design
Designing from Finish to Start
When developing products for a value-based environment, it can be helpful to consider the end result first.Steve Maylish and Vicki Caiati 05.03.18
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Diagnostics
Theranos: Not Long for the Business World?
It won’t be long now. With a skeleton staff, dwindling finances, a sullied reputation, and a disgraced leader under criminal investigation, embattled blood testing firm Theranos Inc. seems veritably destined for a terrible, miserable, no goo…Michael Barbella, Managing Editor 05.03.18
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Pharma Industry’s Growth—What Can Medtech Learn from It?
Global revenues for our sister industry—pharmaceuticals—continues to grow (Table 1). By 2022, worldwide pharmaceutical sales are projected to reach an estimated $1.4 trillion at a CAGR of 6.4 percent from 2001 sales of $390 billion.2 That…Maria Shepherd, President and Founder, Medi-Vantage 05.03.18
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The Right Vendors Foster Growth: Why Firms of All Sizes Need to Outsource
I was working as a product development engineer at AcroMed (a spinal implants manufacturer that was acquired by DePuy in 1998), when I noticed a gap in the medical device industry. There were plenty of companies coming up with great ideas for d…Dawn A. Lissy, President & Founder, Empirical 05.03.18
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Software & IT
Embracing the Digital Evolution for Content Management
Digitalization, global expansion, and changing compliance requirements are driving medical device manufacturers to rethink their commercial models with a specific focus on content management. The industry’s move toward digital has caused a prol…Terri Howard, Director of Commercial Strategy, Medical Device and Diagnostics, Veeva Systems 05.03.18
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13485:2016—Beyond the Risk Management File
Many companies currently are transitioning from ISO 13485:2003 to ISO 13485:2016, the updated standard drafted to help medtech firms evolve with the industry and address changes in the underlying ISO 9001 benchmark. Some companies, however, are findi…James A. Dunning, Principal, QPC Services LLC 05.03.18
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Medical Devices and the Political Climate of 2018: An Update from the Swamp
The November midterm elections have the potential to shift the power balance, leadership, and legislative agenda of Congress, which would certainly have a sizable impact on the medical device industry. In addition to what lies ahead, current actions…Jeffrey J. Kimbell and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 05.03.18
- Diagnosing Breast Cancer with an Imaging Pill
- StimGuard's Battery-Free, Wireless SNS for Overactive Bladder Wins CE Mark
- FDA Approves Industry’s First Off-the-Ear Audio Processor with Wireless Charging
- New Blood Test Rapidly Detects Signs of Pancreatic Cancer
- FDA Approves Second U.S. Study of Therapy Aimed at Better Treating Urethral Strictures
- C&K Acquires Vuillermoz
- Surgeons Use 3D Printing for Two-Year-Old's Life-Saving Kidney Transplant
- LivaNova Receives CE Mark for VNS Therapy SenTiva Generator
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