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Medical Device Designers' Guide to FDA’s Substantial Equivalence

March 9, 2015 11:15 am | by Quynh Hoang, Lynette Zentgraft, Senior Regulatory Experts; Elaine Tseng, Partner, King & Spalding | Articles | Comments

A Premarket Notification or “510(k)” submission is the most common pathway by which medical devices receive authorization to enter the U.S. market, with over 3,500 510(k)s submitted to the U.S. Food and Drug Administration (FDA) yearly. FDA...

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Heavy-Duty Dry Vacuums

March 9, 2015 10:44 am | by Exair Corporation | Exair Corporation | Product Releases | Comments

Independent laboratory tests now certify that EXAIR’s Heavy Duty Dry Vac meets the rigorous safety, health and environmental standards of the European Union that are required to attain the CE mark. The Heavy Duty Dry Vac is a rugged, industrial duty vacuum cleaner that has been...

Fluid-Based Gating Mechanism for Filtering Blood and Fluid Samples

March 9, 2015 10:38 am | by Wyss Institute for Biologically Inspired Engineering at Harvard | News | Comments

In nature, pores can continuously control how a living organism absorbs or excretes fluids, vapors and solids in response to its environment; for example, tiny holes invisible to the naked eye called stomata cover a plant's leaves and stems as...

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Mobile App Provides User-Friendly Platform for Blood Donors

March 9, 2015 10:32 am | by New York Blood Center | News | Comments

New York Blood Center (NYBC) recently launched a new mobile app providing a convenient, user friendly platform for blood donors to find donation locations, make and manage appointments, view donation history and donor profiles, and access...

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Wireless Sensors for Treatment of Obesity and Diabetes

March 9, 2015 10:28 am | by Gentag, Inc. | News | Comments

Mayo Clinic and Gentag, Inc. have reached an agreement to develop the next generation of wearable biosensors designed to fight obesity and diabetes. “We are hoping that this technology will be game-changer. These patch biosensors may help us...

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Buck Regulator

March 9, 2015 10:25 am | by Intersil | Product Releases | Comments

Intersil Corporation, a provider of innovative power management and precision analog solutions, today announced the ISL8002B synchronous buck (step-down) switching regulator that delivers up to 2A of continuous output current from a 2.7V to 5.5V input supply. The device’s 2MHz switching...

Prize-Winning Two-Photon Microscopy Examines Individual Neuron Function

March 9, 2015 9:52 am | by Grete Lundbeck European Brain Research Foundation | News | Comments

The world's most valuable (€1m) neuroscience prize, The Brain Prize has been awarded, to four scientists, Winfried Denk and Arthur Konnerth (Germany), and Karel Svoboda and David Tank (USA), for the invention and development of two-photon...

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'Heart-on-a-Chip' Could Replace Animal Testing for Drug Screening

March 9, 2015 9:16 am | by University of California - Berkeley | News | Comments

When University of California, Berkeley, bioengineers say they are holding their hearts in the palms of their hands, they are not talking about emotional vulnerability. Instead, the research team led by bioengineering professor Kevin Healy...

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'Nanobody' Detects and Destroys Norovirus

March 9, 2015 9:01 am | by German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) | News | Comments

Infection with highly contagious noroviruses, while not usually fatal, can lead to a slew of unpleasant symptoms such as excessive vomiting and diarrhea. Current treatment options are limited to rehydration of the patient. "Additionally...

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Miniaturization is a Prerequisite when Operating Within the Body

March 8, 2015 9:30 am | by Zahl Cama, Quality Manager, American Swiss Products, Co. | American Swiss Products Co., Inc. | Blogs | Comments

It's almost a prerequisite when (no pun intended) operating within the body – or even in more abstract research environments – that the devices and instruments have to be small. The fact is that miniaturization – even sub-miniaturization...

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Shifting Paradigm in Healthcare Industry

March 8, 2015 9:30 am | by BCC Research | News | Comments

BCC Research reveals in its new report on minimally invasive surgery (MIS) devices and equipment, the growing number of surgical procedures has created a multibillion-dollar market for specialized devices and instruments used for these practices...

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Get to Know the Design Rules at This Scale

March 7, 2015 8:30 am | by Shawn Martin, Sales Manager, Metrigraphics, LLC | Metrigraphics, LLC | Blogs | Comments

From our perspective, we look at it more as, “how is medical design impacting miniaturization?” As a micron-scale process developer and manufacturer, we’re receiving more and more requests from biosensor and device designers looking to...

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Next-Generation Viral Load Assay for HBV

March 7, 2015 8:30 am | by Roche | News | Comments

Roche announced today the commercial availability of the cobas HBV quantitative nucleic acid test for use on the cobas 6800/8800 Systems—adding to the viral load monitoring portfolio on the newest molecular diagnostic platforms from Roche...

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Stainless Steel Rotary Vane Pumps

March 6, 2015 3:58 pm | by Clark Solutions | Product Releases | Comments

Clark Solutions announces its PA Series Stainless Steel Rotary Vane Pumps. PA Series pumps are an excellent choice for a very wide variety of applications, including beverage handling systems, reverse osmosis and ultra-filtration systems, cooling and temperature control systems, misting systems...

SS Turbine Flow Meter / Flow Sensor

March 6, 2015 3:55 pm | by Clark Solutions | Product Releases | Comments

Clark Solutions introduces the SS Turbine Flow Meter / Flow Sensor. Featuring a unique and revolutionary Infrared Reflected Digital Output Technology, these flow meters/flow sensors provide highly accurate flow monitoring and totalizing for liquids in pressures up to 363PSI. The flow sensors...

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