LEAD STORIES

Covidien Issues Recalls For Two Medical Devices

Covidien recently issued voluntary recalls for certain lots of its Pipeline embolization device and its Alligator retrieval device, due to a polytetrafluoroethylene (PTFE) coating delamination and detachment issue on their delivery wires. The company is not yet aware of any patient injuries or deaths as a result of the life-threatening flaw.

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  Researchers Regenerate A Living Organ For The First Time
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  Powering Medical Devices With Heartbeats And Breathing Lungs
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  FDA Issues New Guidance On Communication During Device Reviews

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  7 Steps To Survive Your Next Device Compliance Audit

  Practical tips for successfully meeting global regulations and notified body expectations

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  Will Dissolvable Electronics Revolutionize Implantable Device Design?

  Researchers at Iowa State University recently reported success in using a particular type of degradable polymer as the platform for dissolvable electronics, a development that could significantly impact the design of dissolvable electronic medical devices in the future.

ARTICLES

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  Validating Medical Heat Sealers: Process Control That Goes Beyond Time, Temperature, And Pressure

  Validating the heat sealing process is thus critical both to comply with regulatory oversight and to be confident in the overall quality of the final product.

FROM THE EDITOR

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  The Toxic Killers Of Innovation — And 3 Simple Rules For Avoiding Them

  Meet Pete Rosencrans. Pete's an R&D design engineer at a medical device maker, and he’s been tasked with overseeing the research, ideation, and design for a new medical device. He’s faced with gathering input from numerous stakeholders and incorporating it into a final design that pleases everyone. Oh, and his boss wants the device to look great and be fully functional within a matter of months. Sound familiar?

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  Photonics And The Future Of Medicine

  Photonics West serves as the perennial indicator of market trends for the photonics and optics industries. At this year’s event, held last month in San Francisco, one of the pervasive themes I observed in both the technical conference and the exhibition was the increasing role photonics and optics are playing in the development of advanced biomedical technologies. That trend is poised to continue well into the future. 

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  3D Printing In Medicine: 4 Questions That Need To Be Answered

  Almost everyone would agree that 3D printing has a bright future in the medical device industry. So what’s holding it back? This article poses four questions the industry must answer before 3D printing can reach its full potential in medicine.

INDUSTRY PERSPECTIVES

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  7 Steps To Survive Your Next Device Compliance Audit

  Practical tips for successfully meeting global regulations and notified body expectations

PRODUCT SHOWCASE

Optical Thickness Gauge: 157 Series

The Model 157 Optical Thickness Gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products. High accuracy and exceptional repeatability results in the most reliable measurement available. Straightforward operation and rugged design satisfy the needs of the R&D scientist and the manufacturing engineer.

Imaging Couplers

These imaging couplers are designed to connect to an endoscope in order to provide high resolution and high definition images. This is particular useful in medical procedures like surgery, gastrointestinal and respiratory tract observation, and more.

Benchtop Laser Controller: EM595

The EM595 is a benchtop device used to control Gooch & Housego’s line of 14-pin DFB lasers or single-mode lasers. It combines a laser driver and a TEC controller into a 111 mm x 73.5 mm x 169.2 mm (with elements) package and weighs just 1.0 kg.

Micro Optics

Ross Optical’s line of micro optics includes achromats, plano convex lenses, and bi-convex lenses. They’re typically used in compact or miniature optical systems, medical devices, and in optical fibers. These optical components allow for shorter focal lengths in compact systems and feature diameters from sub-millimeter to 6mm.

Laser Rotary Encoders For Highly Accurate Angle Sensing

Canon USA has developed laser rotary encoders that can provide 81,000 pulses with a 36mm diameter. This is done through the use of the light-diffraction interference method in conjunction with a semiconductor laser acting as the light emitting element. The result is a family of laser rotary encoders that provide highly accurate angle sensing for applications involving robotic engineering, stage position control, direct motor control, measurement instruments, and more.

Medical RF & Microwave Semiconductors

Skyworks offers low noise amplifiers, power amplifiers, general purpose amplifiers, mixers, modulators, demodulators, switches, attenuators, detectors, directional couplers, and other components and subsystems from the antenna connection to the baseband input. These products are used in blood sugar (glucose) monitoring, defibrillators, hearing aids, heart monitors/pacemakers, MRI scanners, patient monitors, and other medical devices.

LATEST HEADLINES

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  Covidien Issues Recalls For Two Medical Devices

  Covidien recently issued voluntary recalls for certain lots of its Pipeline embolization device and its Alligator retrieval device, due to a polytetrafluoroethylene (PTFE) coating delamination and detachment issue on their delivery wires. The company is not yet aware of any patient injuries or deaths as a result of the life-threatening flaw.

• Fast, High Definition, Low Dose: GE Healthcare Announces FDA Clearance Of Revolution CT

  GE Healthcare, a unit of General Electric Company, recently announced U.S. FDA 510(k) clearance of its Revolution CT^, which will enable physicians to diagnose even the most challenging patients. 

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  Researchers Regenerate A Living Organ For The First Time

  A team of scientists at the University of Edinburgh, in Scotland, successfully regenerated a living organ for the very first time — an accomplishment that could prove groundbreaking in the field of tissue regeneration.

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  Powering Medical Devices With Heartbeats And Breathing Lungs

  An interdisciplinary group of researchers from Northwestern University, the University of Illinois at Urbana-Champaign, and the University of Arizona have developed a flexible medical device capable of capturing enough electrical power from the natural motions of a beating heart or a breathing lung to power pacemakers, defibrillators, and heart-rate monitors.

• Reverse Medical Corporation Announces FDA IDE Approval For The BARREL Vascular Reconstruction Device For The Treatment Of Intracranial Bifurcation Aneurysms

  Reverse Medical Corporation recently announced FDA IDE approval for clinical investigation of their BARREL Vascular Reconstruction Device (VRD). 

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  Boston Scientific Announces FDA Approval Of Innovative New Defibrillators And Heart Failure Devices

  Boston Scientific Corporation (NYSE: BSX) has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care.

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  Intelligent Prosthetic Liners Could Ease Pain For Lower Limb Amputees

  A new device could help to relieve the pain and discomfort experienced by thousands of amputees as a result of poorly fitting replacement lower limbs. 

• Integrating Consumer Wearable Health Devices Will Drive Healthcare Big Data Adoption

  ​This year close to 42 million wearable wireless sports, fitness and wellness devices will ship worldwide.

FEATURED SUPPLIERS

Canon USA, Inc.

Canon Optoelectronic Components, Integrating the Latest Technologies. Canon has been developing industrial components with super-high levels of precision and accuracys using its optical technologies gained and accumulated for over half a century.