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FDA Clearance for Philips' AlluraClarity X-Ray System

July 8, 2013 11:08 am | by PRNewswire | News | Comments

In close collaboration with leading clinicians in the field of minimally-invasive medicine, Philips has been driving innovation in interventional imaging for more than 50 years, helping to guide procedures such as the catheter-based treatment of obstructed coronary arteries, brain aneurysms, heart rhythm disorders and defective heart valves.

FDA wants to downgrade blood access devices

July 8, 2013 10:57 am | by Mass Device | News | Comments

The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category. The federal watchdog agency said there's enough safety and efficacy data to peel off a layer of regulatory oversight.

FDA plows forward with researcher misconduct privacy rule

July 8, 2013 9:29 am | by Mass Device | News | Comments

The FDA this month issued a rule that would keep confidential certain records pertaining to investigations into potential researcher misconduct at the National Institutes of Health, exempting such documents from federal Privacy Act requirements.

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Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers

July 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document describes and explains the Food and Drug Administration’s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.

CorMedix Receives CE Mark for Neutrolin Catheter Lock Solution

July 5, 2013 11:05 am | by Business Wire | News | Comments

CorMedix has announced that it has received CE Mark approval for Neutrolin, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial combination that is active against common microbes.

Working together for new solutions to cancer in children

July 3, 2013 8:29 am | by Mass Device | News | Comments

One of the greatest pleasures I have as FDA commissioner is the opportunity to meet with so many who are making a real difference in the world of health care, including researchers, doctors, drug industry leaders, foundations, and advocates for patients and families, including most recently the Alexandria Summit for Oncology. 

E.U. scrutinizes medtech review "shopping"

July 3, 2013 7:29 am | by Mass Device | News | Comments

Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices. Specifically, the European Commission's proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.

Integra LifeSciences recall affects Medtronic's Infuse kits

July 2, 2013 12:53 pm | by Mass Device | News | Comments

Minnesota medical device giant Medtronic (NYSE:MDT) confirmed today that it recalled certain of its already-troubled Infuse spinal fusion surgery kits after learning of possible contamination in sponges manufactured by Integra Lifesciences.  

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Class I Medical Device Recall: Medtronic Sutureless Connector Intrathecal Catheter Products ? Catheter Occlusion

June 28, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Sutureless Connector Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion, which is the blockage or stoppage of drug flow due to misalignment at the point where the catheter connects to an implantable pump. Medtronic is removing all unused products that were manufactured with the previous design.

Class I Medical Device Recall: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps - Failure of Priming Bolus

June 28, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps (SynchroMed Implantable Infusion Pumps) contain and administer prescribed drugs to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorph, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen.

Implanted Blood Access Devices for Hemodialysis - Draft Guidance for Industry and Food and Drug Administration Staff

June 27, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document provides draft recommendations for complying with special controls being proposed to support reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed...

Powering the Homecare Medical Device Market

June 26, 2013 2:54 pm | by John Benatti, Field Applications Engineer, Astrodyne | Articles | Comments

With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.

PMA Final Decisions for April 2013

June 26, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

These 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.

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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.”

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.

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.

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