LEAD STORIES

FDA Chief Details Agency Initiatives To Combat Ebola

FDA Commissioner Margaret Hamburg this week further detailed the agency’s efforts in battling the Ebola outbreak that began in West Africa.

  • Abbott Secures Two Catheter-Based Medical Device Companies
    Abbott Secures Two Catheter-Based Medical Device Companies

    Looking to revitalize its medical device business, Abbott Laboratories moved into the fast-growing electrophysiology market by acquiring heart rhythm company Topera Inc. for $250 million upfront. It also secured the right to buy ablation therapy company Advanced Cardiac Therapeutics Inc. in the future for an undisclosed sum.

  • Wright Medical And Tornier Merge In A $3.3B Tax Inversion
    Wright Medical And Tornier Merge In A $3.3B Tax Inversion

    U.S.-based Wright Medical Group and Netherlands-based Tornier have entered into an all-stock inversion deal worth $3.3 billion that will create a new company focusing on three high-growth areas in orthopedics.

  • New Urine Test Can Detect Cancer In Minutes
    New Urine Test Can Detect Cancer In Minutes

    A new point-of-care urine test enables the rapid detection of disease markers in urine at extremely low concentrations. The test, which incorporates a new, microfluidic lab-on-a-chip, can detect a disease by analyzing how far a sample travels through the device’s tubing.

INDUSTRY PERSPECTIVES

  • What To Expect From The Upcoming ISO 13485 Revisions, Part 2
    What To Expect From The Upcoming ISO 13485 Revisions, Part 2

    The International Organization for Standardization (ISO) is currently in the process of revising ISO 13485, the international quality standard for medical devices. When the final version is released — potentially in 2015 — it will be the first revision to the standard in over a decade. In this three-part article series, we are looking at the proposed changes to ISO 13485, to help you prepare for its eventual publication and enforcement.

  • Responsible Disclosure: 8 Security Mistakes You Don’t Know You’re Making
    Responsible Disclosure: 8 Security Mistakes You Don’t Know You’re Making

    Imagine this scenario: Your company has received an unsolicited email from someone who claims to be a security researcher. This person has broken into one of your medical devices, and reverse engineered the code. In the process, she has discovered a potential security vulnerability that could put patient safety at risk if exploited — and now she wants to tell you about it.

  • Understanding The UDI Rule – A Guide For Medical Device Manufacturers
    Understanding The UDI Rule – A Guide For Medical Device Manufacturers

    The FDA’s UDI (unique device identification) final rule has arrived, and medical device manufacturers are working on their implementation strategies. The first compliance date — for Class III devices produced after September 24, 2014 — passed last month, and additional deadlines are coming up quickly. This article provides an introduction to important UDI concepts and explains the steps manufacturers should be taking to get moving on on UDI compliance. 

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ARTICLES

  • Benefits Of Using Micro Pumps And Miniature Valves In Sidestream Capnography
    Benefits Of Using Micro Pumps And Miniature Valves In Sidestream Capnography

    Sidestream capnography measure the concentration of CO2 expelled in respiratory gases by pulling a sample of a patients’ exhaled gas from a breathing circuit through tubing that directs itself to an infrared sensor in a remote patient monitor. This white paper discusses the advantages of using micro pumps as well as miniature valves in this measurement technique.

Bringing Radiology And X-ray Imaging To The Wounded Warrior

The transformation from the traditional X-ray film to digital detectors has occurred within the last two decades, which led to the elimination of process chemicals, time delays for developing, and to the arrival of nearly instantaneous image viewing, transmission, and storage. Now a similar transformation is set to occur for the X-ray source.

Miniature Camera Modules For Visualizing Micro Invasive Surgery

The miniaturization of camera modules allows visualization inside the body with ever smaller incisions. These miniature digital camera modules — hardly bigger than a grain of salt — enable novel medical tools, where visualization is possible for the first time and where previous procedures had to be done completely blind. In this article, AWAIBA, a reputed leader in miniature camera modules as small as 500 mm side length, provides an overview of these miniaturized cameras and explores potential new applications for the technology.

The Evaluation Of Increase And Distribution Of Temperature During The Dental Drilling Using A Thermal Imaging Camera

This paper discusses the use of infrared technology to study the optimal method for post space preparation of teeth including how long to drill, the type and size of dental drill used, and the type of cooling used. By Joanna Lubieniecka, M. Sc. Eng., Jerzy Lukasiewicz, M. Sc. Eng., Joanna Bozyk, MDS, and Janusz Kleinrok, DMD

Intelligent Fluid Couplings Communicate Critical Device And Process Data

Like many other devices these days, a select group of fluid connectors can now be found in the growing ranks of “intelligent” products. In addition to moving fluids, these high-tech connectors move data, thanks to the innovative use of wireless communication technology. This article outlines the benefits of implementing RFID-enabled couplings into a fluid handling system. By Dennis Downs, Colder Products Company

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FROM THE EDITOR

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2

    In the crucible that is today’s healthcare environment, medical device companies can no longer wait until they have regulatory approval or clearance to begin pursuing reimbursement for their products. Nor can they approach regulatory and reimbursement activities as completely independent initiatives. A more tactical, integrated methodology is required.

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1

    When Kevin Conroy joined Exact Sciences as president and CEO in April 2009, the company had a novel, highly accurate, and noninvasive diagnostic technology for the early detection of colorectal cancer — and a potentially huge market. It was also low on capital. Conroy and his team estimated that product development and separate clinical trials to satisfy FDA and CMS requirements would take the better part of a decade to complete, and there was no way to finance the company for that long. Yet here we are, less than six years later, and Exact Sciences’ Cologuard test has obtained both FDA approval and a CMS coverage. How did the company's prospects shift so dramatically? It all began with one fateful meeting.

  • 5 Keys To Protecting Your Medical Device From Cybersecurity Threats
    5 Keys To Protecting Your Medical Device From Cybersecurity Threats

    In this nascent era of connected healthcare, medical devices must be evaluated in a much broader context than simply a series of discrete patient engagements. They should be viewed as the basic building blocks of a massive national biomedical device network, one that undergirds our nation’s entire healthcare infrastructure. Unfortunately, they are also the most vulnerable components of that system. Learn how to protect your devices, the national network, and patients from malware and hackers.

More From The Editor

PRODUCT SHOWCASE

Solder-In Filters

Solder-In Filters

Many designers have opted to semi-integrate feedthrus by soldering feedthrus directly into the housings. The solder-in feedthrus are available in a glass forward or reverse seal.
Optical Solutions For Medical Devices

Optical Solutions For Medical Devices

Ross Optical’s medical optics experts have assisted in turn-key design engineering for ophthalmic instruments, spectrum analyzers, laparoscopic instruments, endoscopes, medical eyeglass binoculars, and instrumentation for Lasik eye surgery.

SnapShot Multispectral Camera: PixelCam

SnapShot Multispectral Camera: PixelCam

The PixelCam is a multispectral camera ideal for applications involving aerial mapping, product screening, water quality measurement, biomedical imaging, machine vision, surveillance, and authentication. The camera can also be customized for integration into OEM products.

Medical Device Design Services: PTI Design

Medical Device Design Services: PTI Design

PTI has been assisting medical device companies with product design and development for over 25 years. Their design and development studio combines state-of-the-art technology with experience in bringing medical devices to market.

CMOS Sensor Endoscopes

CMOS Sensor Endoscopes

In the construction of endoscopes with distal end CMOS sensors, Precision Optics Corporation (POC) utilizes proprietary micro lens design and manufacturing capabilities to build camera assemblies using numerous different CMOS sensors.

Liquid Silicone Rubber Injection Molding

Liquid Silicone Rubber Injection Molding

Liquid silicone rubber (LSR) molding is a thermoset process that mixes a two-component compound together, which is then heat cured in the mold with a platinum catalyst to produce a final part. Liquid Silicon Rubber parts are formed through an injection-molding process similar to that of conventional plastic injection molding with one major difference — the material delivery system is cooled and the mold is heated. Liquid silicone rubber possesses thermal, chemical and electrical resistance, plus biocompatibility. Also, Liquid Silicone Rubber parts can withstand sterilization while maintaining physical properties at extreme temperatures.

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LATEST HEADLINES

  • FDA Chief Details Agency Initiatives To Combat Ebola
    FDA Chief Details Agency Initiatives To Combat Ebola

    FDA Commissioner Margaret Hamburg this week further detailed the agency’s efforts in battling the Ebola outbreak that began in West Africa.

  • Biomet Settles Kickback Lawsuit, Agrees To Pay $6 Million
    Biomet Settles Kickback Lawsuit, Agrees To Pay $6 Million

    In an agreement that admits no liability, orthopedic giant Biomet agreed to a $6 million settlement with the U.S. Department of Justice (DOJ). Allegations of the lawsuit included the bribing of physician’s office employees to increase sales.

  • Sweat Sensors Could Bring Medical Diagnostics To Wearables
    Sweat Sensors Could Bring Medical Diagnostics To Wearables

    Wearable technology, like that seen in the fitness space, is making a transition to medical diagnostics. By analyzing sweat, a new patch can identify cystic fibrosis and may one day be used for monitoring blood glucose levels.

  • Concussion-Monitoring Mouthguard Coming To Market
    Concussion-Monitoring Mouthguard Coming To Market

    A sensor system placed inside a new mouthguard design could provide real-time alerts on concussions during high-impact activities. Data from the device could inform coaches and parents on when someone needs to get further evaluation from a doctor.

  • Abbott Secures Two Catheter-Based Medical Device Companies
    Abbott Secures Two Catheter-Based Medical Device Companies

    Looking to revitalize its medical device business, Abbott Laboratories moved into the fast-growing electrophysiology market by acquiring heart rhythm company Topera Inc. for $250 million upfront. It also secured the right to buy ablation therapy company Advanced Cardiac Therapeutics Inc. in the future for an undisclosed sum.

  • Wright Medical And Tornier Merge In A $3.3B Tax Inversion
    Wright Medical And Tornier Merge In A $3.3B Tax Inversion

    U.S.-based Wright Medical Group and Netherlands-based Tornier have entered into an all-stock inversion deal worth $3.3 billion that will create a new company focusing on three high-growth areas in orthopedics.

  • New Urine Test Can Detect Cancer In Minutes
    New Urine Test Can Detect Cancer In Minutes

    A new point-of-care urine test enables the rapid detection of disease markers in urine at extremely low concentrations. The test, which incorporates a new, microfluidic lab-on-a-chip, can detect a disease by analyzing how far a sample travels through the device’s tubing.

  • Australian Government To Initiate Review Of Medical Device Regulations
    Australian Government To Initiate Review Of Medical Device Regulations

    A group of experts will review the Australian Therapeutic Goods Administration’s (TGA) framework for the regulation of medical devices and pharmaceuticals, according to a recent government announcement.

More News

UPCOMING TRAINING COURSES

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training

How To Take Advantage Of The Companion Diagnostics Opportunity

November 13, 2014
1pm-2:30pm EST, Online Training

Reducing Human Error in Life Sciences Manufacturing

November 18, 2014
1pm-2:30pm EST, Online Training

Medical Device Supplier Management Programs: Building Compliant Systems

December 9, 2014
1pm-2:30pm EST, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

AR

AR

Since 1969, AR has played a major role in the success of the automotive, medical, military, aerospace and telecom industries. The company’s products are used for a variety of critical applications including RF Test & measurement in a multitude of industries throughout the world. At AR, there’s no substitute for quality. It’s the foundation of our business and the AR value that’s recognized around the globe...