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Class I Medical Device Recall: Medtronic Xomed, Inc., NIM Trivantage EMG Endotracheal Tube

June 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death.

Electromagnetic Interference in Device Design

June 19, 2013 1:57 pm | by Donald L. Sweeney, President, D.L.S. Electronic Systems Inc . | D.L.S. Electronic Systems, Inc. | Blogs | Comments

The greatest obstacle to success in the design of a device is that, often times, the design engineer overlooks the need to keep electromagnetic interference in mind when he designs his device. When a product is not in compliance, it can be interfered with by radio waves emitting from other electronic devices in the home, causing the product to malfunction.

Medical Innovation Will Not Be “Taxed Away”

June 18, 2013 4:43 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

“Take two and call me in the morning.” That’s the phrase that came to mind while preparing a particular article recently. While “Coating for Consumption” doesn’t deal with taking two pills and calling the doctor in the morning, I couldn’t help but think about how far we’ve come since the days when that phrase reflected what most people thought was “modern healthcare.”

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Codman Neuro Obtains CE Mark for Thrombectomy Device

June 13, 2013 4:33 pm | by Codman Neuro | News | Comments

Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has obtained CE marking for REVIVE SE, a next-generation self-expanding clot removal device for use in treating acute ischemic stroke, the company announced today at the Live Interventional Neuroradiology & Neurosurgery Course (LINNC) in Paris.

Court Says Human Genes Cannot Be Patented

June 13, 2013 4:13 pm | by Jesse J. Holland, Associated Press Writer | News | Comments

The Supreme Court ruled Thursday that companies cannot patent parts of naturally-occurring human genes, a decision with the potential to profoundly affect the emerging and lucrative medical and biotechnology industries. The high court's unanimous judgment reverses three decades of patent awards by government officials.

UDI Inspection Guidelines

June 13, 2013 2:06 pm | by Jonathan Ludlow, Machine Vision Promoter, Microscan Systems | Microscan Systems, Inc. | Articles | Comments

New unique device identification labeling rules are on the way for medical devices, so it’s best for engineers to be aware of what impact they may have prior to them being mandatory. This article looks at the main points behind the coming rule and the considerations for ensuring proper symbol quality and label/mark verification.

FDA Safety Communication: Cybersecurity for Medical Devices and Hospital Networks

June 13, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware...

Twenty Patients Implanted in Functional Neuromodulation’s ADvance Study of Deep Brain Stimulation for Alzheimer’s Disease

June 12, 2013 9:07 am | by Business Wire | News | Comments

Functional Neuromodulation Ltd.’s ADvance Study has implanted 20 mild Alzheimer’s patients with deep brain stimulation (DBS) systems, and the U.S. Food and Drug Administration has approved expansion of the study from 20 to 30 U.S. patients in combination with 20 subjects approved in Canada.

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Approval Of Boston Scientific's Watchman Device Will Support Rapid Growth In The Global Heart Defect Closure Device Market

June 12, 2013 8:00 am | by The Associated Press | News | Comments

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the anticipated Food and Drug Administration (FDA) approval of Boston Scientific's WATCHMAN device will drive rapid growth in the market for global heart defect closure devices. ...

Class I Medical Device Recall: Symbios GOPump and GOBlock Kits

June 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness...

Teleflex Receives FDA Clearance for ARROW NextStep Retrograde Femoral Length Dialysis Catheters

June 10, 2013 5:00 pm | by Business Wire | News | Comments

Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced it has received FDA 510(k) clearance to market its ARROW® NextStep® Retrograde Femoral Length Dialysis Catheters. Designed for clinician ease of insertion and sustained high flow rates, the ARROW NextStep Retrograde Femoral Length Catheters further strengthen the NextStep Hemodialysis Catheter portfolio.

Evaluation of Automatic Class III Designation (De Novo) Decision: K121291 added

June 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. The De Novo process applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices.

Consumer Updates - WANTED: Consumers to Report Problems

June 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

A new consumer-friendly form is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.

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Commentary: Obamacare’s Other Surprise

May 25, 2013 7:13 am | by Thomas L. Friedman, Associated Press | News | Comments

We’ll just have to wait and see whether the Affordable Care Act, as the health care law is officially known, surprises us on the downside. But there is one area where the law already appears to be surprising on the upside. And that is the number of health care information startups it’s spurring.

PMA Final Decisions for March 2013

May 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

Class I Medical Device Recall: Cook Medical, Inc., Zilver PTX Drug-Eluting Peripheral Stent

May 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage...

Improving Patient Safety with Unique Device Identification

May 23, 2013 11:35 am | by Warren Ward-Stacey, Sales Director, PRISYM ID | Blogs | Comments

Medical device manufacturers should welcome the proposed ruling for Unique Device Identification (UDI); however, being compliant by the effective date (based on classification) for some organizations may be a concern. UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems.

Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement

May 23, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices.  The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. 

ACRO Joins Coalition of Small Business Innovators

May 21, 2013 11:09 am | by The Associated Press | News | Comments

WASHINGTON--(BUSINESS WIRE)--May 21, 2013--The Association of Clinical Research Organizations announced today it has joined the Coalition of Small Business Innovators (CSBI). CSBI is a national, non-partisan coalition of organizations dedicated to stimulating sustained, private investment in...

BIO Joins Coalition of Small Business Innovators

May 21, 2013 10:30 am | by The Associated Press | News | Comments

WASHINGTON--(BUSINESS WIRE)--May 21, 2013--The Biotechnology Industry Organization (BIO) announced today it has joined the Coalition of Small Business Innovators (CSBI). CSBI is a national, non-partisan coalition of organizations dedicated to stimulating sustained, private investment in small,...

Coalition of Small Business Innovators Launches to Encourage a Tax Code that Creates Jobs and Promotes Long-Term Economic Growth

May 21, 2013 10:00 am | by The Associated Press | News | Comments

WASHINGTON--(BUSINESS WIRE)--May 21, 2013--The Coalition of Small Business Innovators (CSBI) launches today with 15 organizations representing thousands of pre-revenue small businesses that employ millions of Americans in all 50 states. The Coalition aims to promote small business advancement as...

Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer

May 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

It has come to our attention that you are currently marketing the uChek Urine analyzer, which is intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips for the qualitative and semi-quantitative determination of urine analytes including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity. 

Preparing for Medical Electronics RoHS Compliance

May 20, 2013 2:33 pm | by George Karalias, Director of Marketing & Communications, Rochester Electronics | Rochester Electronics | Blogs | Comments

Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.

Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff

May 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. This guidance supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA."

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff

May 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisions..

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