LEAD STORIES

Medtronic Buys Aneurysm Device Developer Medina Medical For $150M

Medtronic has acquired Medina Medical, which has developed an embolization device for treatment of cerebral aneurysm, a major cause of hemorrhagic stroke. The all-cash deal consists of an initial payment of $150 million, plus additional amounts contingent on unspecified milestones, according to a statement from Medtronic.

  • First-Of-Its-Kind Medtronic Study Finds Genetic Markers Of Sudden Cardiac Death Using ICDs
    First-Of-Its-Kind Medtronic Study Finds Genetic Markers Of Sudden Cardiac Death Using ICDs

    Medtronic has announced findings from two independent clinical trials which identified a specific gene that triggers fatal arrhythmias and sudden cardiac death (SCD). The initial trial, sponsored by Medtronic, found a gene that was associated with SCD in patients implanted with ICDs. A second study, called the Oregon Sudden Unexpected Death Study, confirmed the findings of the initial trial in the general population.

  • Google, Sanofi Partner On Diabetes Management
    Google, Sanofi Partner On Diabetes Management

    The team at Google Life Science has inked another partnership with a global leader in diabetes management, Sanofi SA. Though financial details of the deal were not disclosed, both companies expressed enthusiasm at combining their respective expertise to develop next-generation diabetes management devices and software.

INDUSTRY PERSPECTIVES

  • Stop Treating Risk Management & Design Controls As Checkbox Activities
    Stop Treating Risk Management & Design Controls As Checkbox Activities

    Understanding the relationship between product risk management and design controls is critical to the success of a medical device in the marketplace. Both are all too often treated as “checkbox” activities that have to be done because the regulations say so. Read on to see why you should embrace design controls and risk management not just as necessary evils, but as tools to help ensure your medical device is as safe and effective as possible.

  • Left Atrial Appendage Closure Devices — Understanding The Transforming U.S. Market

    The left atrial appendage, is a small cavity located in the wall of the heart's left atrium, has received significant medical literature coverage in recent years for its role in generating stroke-causing blood clots in patients with non-valvular atrial fibrillation. More recently, the devices designed to close the LAA have become a popular subject for debate among AF patients, regulatory officials, and medical device enthusiasts alike. This column examines how the LAA closure device market will evolve over the next seven years. 

  • An Introduction To FDA And FCC Regulations Impacting mHealth
    An Introduction To FDA And FCC Regulations Impacting mHealth

    The world of mobile health, or mHealth — the practice of medicine and public health supported by mobile devices — is continually changing due to the innovative nature of the industry and to the regulatory scheme in place to monitor it, ensuring both patient safety and appropriate consumer access. While recent moves by the FDA have been welcome news to an industry that has requested more regulatory transparency, Federal Communications Commission (FCC) action in the “net neutrality” proceeding has introduced some new risk and uncertainty. 

More Industry Perspectives

FROM THE EDITOR

  • 5 Things We Learned From ‘UDI, Wave One’
    5 Things We Learned From ‘UDI, Wave One’

    Most of the unique device identifier (UDI) wave one rollout isbehind Class III med device companies, so what did we learn to avoid getting washed away by waves two and three? I spoke with Jay Crowley —  formerly CDRH’s Senior Advisor at the FDA and one of UDI's progenitors  about the lessons med device manufacturers can take from ‘UDI, Wave One.’

  • Unhealthy Healthcare Economics: Medtech Innovation As The Cure, Not The Cause
    Unhealthy Healthcare Economics: Medtech Innovation As The Cure, Not The Cause

    The U.S. is on track to spend about $3.2 trillion in healthcare in 2015 (more than the entire GDP of France), and a projected $5.5. trillion by 2024. Yet, life expectancy in the U.S. is actually lower than in countries spending far less. It’s too early to say whether systemic improvements like the Affordable Care Act will be able to reverse this trend, but while we wait around to find out, medical technology has become a popular target for criticism and proposed spending cuts. What if the way out of this mess was to devote more resources to medical technology, not less?

  • Stryker’s MAKO Surgical Acquisition: A Second Look
    Stryker’s MAKO Surgical Acquisition: A Second Look

    At a time everyone was playing follow-the-leader in consolidation, Stryker took a different approach. With the MAKO acquisition, Stryker was bold enough to sacrifice short-term profit for long-term gain. I talked with Stuart Simpson, VP and GM of Stryker Reconstructive Business, about how that gamble could pay off.

More From The Editor

WHITE PAPERS & CASE STUDIES

  • Boxed To Perfect Standards -- The Complex Art Of Medical Packaging

    Packaging for medical devices, related products and materials is highly regulated and must meet very specific requirements. The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device. By Ken Shagagi, Life Science Outsourcing, Inc.

CYA 101: 4 Tips to Help You Cover Your Audit

Audits are a part of doing business for most life sciences companies, but that doesn’t make them any less stressful. If an audit goes badly, it’s a black eye for your company. You could be looking at long product delays, warning letters, consent decrees, recalls, or even a plant shutdown. So, what’s the secret to walking into an audit with confidence? It takes proper planning and the right tools. Here are a few tips to help you be better prepared, so you no longer have to fear the auditor.

Turning To Lathe For Parts With Cylindrical Features

Does your next medical device have cylindrical features? If so, this white paper is for you. Download it to learn how adding a live-tool equipped CNC turning center to an already extensive three-axis milling service can product a better finish on cylindrical features, typically at a lower cost.

5 Practices For Managing Change When ISO 9001:2015 Arrives

Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.

Megatrends Impacting Designs Of Robotics In Life Sciences

There are three megatrends that are rapidly driving changes in the design and use of laboratory automation and robotics. This white paper discusses in-depth how demographic shifts, technology advancements, and commercial realities make their impact in life sciences.

More White Papers & Case Studies

PRODUCT SHOWCASE

RF Diodes For Broadband Applications

RF Diodes For Broadband Applications

Skyworks Solutions offers a select group of their most popular PIN, limiter, Schottky, and tuning varactor diodes that are designed to meet demanding applications, and are available to ship from stock for prototype or high-volume production.

Custom Packaging And Pouching

Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

Manifold Technologies and Techniques

Manifold Technologies and Techniques

For over three decades, the Lee Company Electro-Fluidic Systems Group has been an industry leader in electromechanical valve and pump technology. Their expertise in fluidics is drawn from a complete understanding of the application and components involved. Using a manifold technique, it is possible to incorporate solenoid valves, pumps, passive components and active components into a complete assembly that has been functionally tested per the application requirements.

High-Performance Batteries for Active Implants

High-Performance Batteries for Active Implants

These high-performance batteries are based on lithium-iodine or lithium-manganese dioxide. They feature high volumetric energy densities and low self-discharge. They’ve been specifically designed for use in medical implants.

3D Optical Surface Profiler: ZeGage™

3D Optical Surface Profiler: ZeGage™

The ZeGage™ is a scanning white light interferometer that provides 3D optical surface profiling for the measurement of precision surfaces that require non-contact metrology. Unlike other optical surface profilers, this system maintains high resolution at all seven of its magnification options. It’s also not affected by the environment it operates in. You can take it out of the QA lab, place it directly beside your production equipment, and still get a 3D surface roughness measurement of precision machined surfaces with nanometer level precision.

Cavity Filters

Cavity Filters

Corry Micronics offers a line of cavity filters. We have several stock cavity filters that are designed for specific industries. Some of the more popular stock units are for filtering CDMA repeaters with a Bandpass range of 825 to 835 MHz and other units designed to Bandpass a range of frequencies from 870 MHz to 880 MHz...
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LATEST HEADLINES

  • Medtronic Buys Aneurysm Device Developer Medina Medical For $150M
    Medtronic Buys Aneurysm Device Developer Medina Medical For $150M

    Medtronic has acquired Medina Medical, which has developed an embolization device for treatment of cerebral aneurysm, a major cause of hemorrhagic stroke. The all-cash deal consists of an initial payment of $150 million, plus additional amounts contingent on unspecified milestones, according to a statement from Medtronic.

  • New Implant Offers Electrostimulation Treatment For Idiopathic Scoliosis
    New Implant Offers Electrostimulation Treatment For Idiopathic Scoliosis

    A consortium of European scientists has developed a prototype implant that could provide treatment for young adults suffering from idiopathic scoliosis. By delivering pulses to correct a nerve imbalance in the spinal cord, researchers believe that they could prevent life-threatening deformities with the minimally invasive new method.

  • FDA Approves Wright Medical Group's AUGMENT Bone Graft

    Wright Medical Group, Inc. has announced that its BioMimetic subsidiary has received FDA approval for its Premarket Approval Application (PMA) for AUGMENT Bone Graft.  The approval order indicates that FDA determined that AUGMENT Bone Graft is safe and effective as an alternative to autograft for ankle and/or hindfoot fusion indications.  Wright can now initiate commercial sale and distribution of AUGMENT Bone Graft in the U.S. 

  • FDA, Fogarty Institute Team To Educate Medtech Startups

    The Fogarty Institute for Innovation, a nonprofit that provides intellectual, physical and financial resources to medtech startups, has partnered with the FDA to begin a first-of-its-kind educational program. The goal of the program is to help accelerate medical device innovation by improving communication, collaboration and understanding between the FDA and early-stage medical device innovators, and thereby improve the overall efficiency of the medical device approval process.

  • First-Of-Its-Kind Medtronic Study Finds Genetic Markers Of Sudden Cardiac Death Using ICDs
    First-Of-Its-Kind Medtronic Study Finds Genetic Markers Of Sudden Cardiac Death Using ICDs

    Medtronic has announced findings from two independent clinical trials which identified a specific gene that triggers fatal arrhythmias and sudden cardiac death (SCD). The initial trial, sponsored by Medtronic, found a gene that was associated with SCD in patients implanted with ICDs. A second study, called the Oregon Sudden Unexpected Death Study, confirmed the findings of the initial trial in the general population.

  • Google, Sanofi Partner On Diabetes Management
    Google, Sanofi Partner On Diabetes Management

    The team at Google Life Science has inked another partnership with a global leader in diabetes management, Sanofi SA. Though financial details of the deal were not disclosed, both companies expressed enthusiasm at combining their respective expertise to develop next-generation diabetes management devices and software.

  • Batteries Not Included: Wearables And Bioelectronics Seek Better Energy Storage
    Batteries Not Included: Wearables And Bioelectronics Seek Better Energy Storage

    Energy storage players are eyeing emerging opportunities in bioelectronics as wearable, implantable and other medical devices create energy demands and design requirements beyond conventional batteries, according to Lux Research. 

More News

UPCOMING TRAINING COURSES

Monitoring Electronic Health Records (EHRs): Frequently Asked Questions

September 9, 2015
1pm-2:30pm EDT, Online Training

Laboratory Data Integrity: Current Expectations for OOS Result Investigations

September 16, 2015
1pm-2:30pm EDT, Online Training

Communication With FDA: What Do We Say And How Do We Say It?

September 21, 2015
1pm-2:30pm EDT, Online Training

Root Cause Analysis for GCP – A Risk Action Plan Guide

September 22, 2015
1pm-3pm EDT, Online Training
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FEATURED SUPPLIERS

Heatron, Inc.

Heatron, Inc.

Heatron was founded in 1977 and established a solid business in heating component design and manufacturing.  Our mission to help our customers accelerate their product development process by offering high performance products that differentiates them. With expertise in a multitude of key thermal technologies, our products are engineered to withstand the extraordinary demands placed on them.