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An Outside Perspective: Joining Forces to Bring New Technology to Market

January 5, 2012 10:53 am | by John Havard | Articles | Comments

Medical device manufacturers that attempt to handle too many tasks in the product development process without the sufficient level of competency are simply setting themselves up for failure. It is vital for them to maintain a strong expertise in those core competencies and look outside for strategic partners who can aid them. This article examines that for the product design process.

Accelerating Cancer Diagnosis with Customized Motion Control

January 5, 2012 9:58 am | by Scott Frederick | Articles | Comments

The Challenge: A large OEM needed a consistent motion controller for a 84-slide capacity IHC benchtop autostain machine. The Solution: A customized, four-axis 1/2-stack motion controller was selected that ran inside the OEM customer’s existing PC, reducing cost for the manufacturer and increasing lab space for the end-user.

Perspectives on Miniaturization

January 5, 2012 9:47 am | Articles | Comments

In the effort to make medical devices smaller, what has been the most challenging obstacle you have faced and how were you able to resolve this problem?

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CircuLite Awarded Grant from Cardiovascular Medical Research and Education Fund to Develop Right-Heart Circulatory Support System for Patients with Pulmonary Arterial Hypertension (PAH)

January 5, 2012 5:27 am | News | Comments

SADDLE BROOK, N.J.--(BUSINESS WIRE)--CircuLite®, Inc. today announced that it has received a grant from the Cardiovascular Medical Research and Education Fund, Inc. (CMREF) to fund the development of a right-heart circulatory support system based upon CircuLite's Synergy® Micro-pump...

Regulatory Harmonization Institute: First Not-For-Profit Organization Dedicated to Global Harmonization of Drug and Medical Device Regulatory Requirements

January 5, 2012 5:24 am | News | Comments

ELMWOOD PARK, N.J.--(BUSINESS WIRE)--The Regulatory Harmonization Institute, Inc. (RHI) an international, not-for-profit association dedicated to global harmonization of drug and medical device regulatory requirements, today announced the launch of its Web site, programs and initiatives...

GI Dynamics Announces Commercial Availability of the EndoBarrier for the Treatment of Type 2 Diabetes or Obesity in the Netherlands

January 5, 2012 5:20 am | News | Comments

LEXINGTON, Mass. & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. today announced the transition of the EndoBarrier® Gastrointestinal Liner (the EndoBarrier), a novel, non-surgical device for the treatment of type 2 diabetes and/or obesity, from clinical research to commercial use in the Netherlands.

Roche and Itamar-Medical Move Forward in Developing EndoPAT for Pre-Clinical Longitudinal Studies

January 5, 2012 5:15 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Itamar-Medical, the world's leader of non-invasive devices for diagnosis of cardiovascular health, announced achievement of the next milestone of the international pharmaceutical company, Roche, to further develop the EndoPAT technology for pre-clinical trials.

Medtronic Launches First-of-Its-Kind mySentry Remote Glucose Monitor

January 5, 2012 5:12 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Today, Medtronic, Inc. announced U.S. Food and Drug Administration (FDA) approval and U.S. market launch of the first-of-its-kind mySentryâ„¢ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient's MiniMed...

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Ensil Canada Ltd. Markham, Ontario, Canada, Today Announced the Validation of a 5-Minute, Non-Invasive HIV Test at its Laboratories in Ontario, Canada

January 5, 2012 5:07 am | News | Comments

MARKHAM, ON/24-7PressRelease/ -- After several years of scientific and biomedical laboratory experiments, Ensil succeeds in developing a nanotechnology-based sensor to detect gp 21 and gp 27 HIV virus through urine.

Implantable Pulse Generators ‘Stimulate’ Medical Device Industry

January 4, 2012 11:46 am | by Chris Vaillancourt | Articles | Comments

In recent years, there has been great excitement about the use of neuromodulation to treat a wide array of medical conditions and diseases. The technology uses electrical signals to stimulate or block different nerve impulses in the body and is adapted from technology used in cardiac rhythm management. Advanced ceramic materials are playing an important role in the technology and are poised to play an even greater one as these medical devices flood onto the market to treat an increasing number of ailments.

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

January 4, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.

Class I Medical Device Recall: Ikaria INOmax DS Drug Delivery System

January 4, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Fretting corrosion at the electrical contact interface of certain metals was the root cause for erratic nitric oxide (NO) monitoring readings. Adverse consequences may include inadequate oxygen reaching the tissues in the body...

SeptRx reports first 20 patients have been enrolled in its “InterSEPT" CE Mark trial of the SeptRx Intrapocket PFO Occluder

January 4, 2012 5:44 am | News | Comments

FREMONT, Calif.--(BUSINESS WIRE)--SeptRx, an emerging medical device company that has developed the SeptRx® Intrapocket PFO Occluder (IPO) - a platform for the percutaneous transcatheter closure of a heart defect known as patent foramen ovale (PFO) - reported today that it has completed...

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BSD Medical Approaches 100 Patients Successfully Treated with the MicroThermX Microwave Ablation System at Hospitals Throughout the U.S.

January 4, 2012 5:41 am | News | Comments

SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation, a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company is approaching 100 patients successfully treated with the MicroThermX® Microwave Ablation System...

GlobalMed Introduces New Mobile Telemedicine Carts and Tablet PC with HP

January 4, 2012 5:38 am | News | Comments

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--GlobalMed today announced it is partnering with HP to introduce three new mobile telemedicine carts and a tablet PC solution powered by HP Workstations and EliteBook PCs that will bring doctors and patients together for clinical healthcare at a distance.

BioLineRx Announces Initiation of CE Mark Registration Trial for BCM (BL-1040), a Novel Medical Device for Prevention of Cardiac Remodeling Following Acute Myocardial Infarction

January 4, 2012 5:35 am | News | Comments

JERUSALEM--(BUSINESS WIRE)--BioLineRx, a biopharmaceutical development company, announced today the commencement of the PRESERVATION I clinical trial, a CE Mark registration trial of BCM (BL-1040), a novel medical device intended for the prevention of cardiac remodeling...

AirStrip Technologies Receives CE Mark for Mobile Patient Monitoring Solutions

January 4, 2012 5:29 am | News | Comments

SAN ANTONIO--(BUSINESS WIRE)--AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe, company officials announced today.

Welch Allyn President & CEO Announces Intention to Retire

January 4, 2012 4:58 am | News | Comments

Skaneateles Falls, N.Y., January 3, 2012 - Welch Allyn, a leading manufacturer of frontline medical products and solutions, announced today that Julie Shimer, president & CEO of the company for the past five years, has announced her intention to retire at the end of this year.

CLSI Publishes 2012 Antimicrobial Susceptibility Testing Standards

January 4, 2012 4:54 am | News | Comments

Wayne, Pennsylvania, USA-January 2012-The Clinical and Laboratory Standards Institute (CLSI) recently published updated editions of its antimicrobial susceptibility testing (AST) standards, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard-Eleventh Edition...

Inertial Measurement Sensing Technology Enables Surgical Precision

January 3, 2012 10:31 am | by Bob Scannell | Analog Devices, Inc. | Articles | Comments

Recent innovations in computer-assisted surgery are pushing the boundaries of modern medicine to new and exciting frontiers. As conventional surgical instrumentation continues to give way to advanced console- and camera-based systems, surgeons are able to operate on patients with exceptional precision.

How to Build the ‘Right System’

January 3, 2012 6:29 am | by Uday Gurnani and Gene Frantz | Articles | Comments

In the field of electronics design, designing a “best in class” product with a competitive roadmap for the future is vital. For medical designs, in particular, it is especially important to use the highest quality components to ensure longevity, as these products go through long approval and use cycles. To accomplish this, system designers need to design the “right system.” But what does that mean?

Proto Labs Announces SkyLight as Latest Cool Idea!

January 3, 2012 4:41 am | News | Comments

MAPLE PLAIN, Minn. – Dec. 28, 2011 – The latest recipient of the Proto Labs Cool Idea! Award, SkyLight, aims to make a big impact on global healthcare and science education. Proto Labs – the leading online and technology-enabled manufacturer of quick-turn prototype and short-run parts...

Presage® ST2 Assay Enters Routine Use for Heart Failure Patient Care

January 3, 2012 4:34 am | News | Comments

SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that a major European medical center, Hospital Germans Trias i Pujol in Barcelona Spain, is now using the company's Presage® ST2 Assay for routine care...

Hospitals, Healthcare Providers to Benefit from New Premier Agreements For MRI Compatible Equipment

January 3, 2012 4:32 am | News | Comments

CHARLOTTE, N.C.--(BUSINESS WIRE)--The Premier healthcare alliance today announced new agreements for MRI compatible equipment have been awarded to Invivo Corporation of Orlando, Fla.; IRadimed Corporation of Winter Park, Fla.; and Medrad, Inc. of Indianola, Pa.

Devicemakers Schooled on How to Respond to Off-Label Information Requests

December 30, 2011 4:31 pm | by U.S. Food & Drug Administration | News | Comments

Devicemakers responding to unsolicited requests for off-label product information are urged to keep conversations private and specific to the requester’s inquiry, according to a new FDA draft guidance.

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