Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for ManufacturersJuly 8, 2013 12:00 am | by U.S. Food & Drug Administration |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This draft guidance document describes and explains the Food and Drug Administration’s current regulation that addresses reporting and recordkeeping requirements applicable to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 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.
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.
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.
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.
Class I Medical Device Recall: Medtronic Sutureless Connector Intrathecal Catheter Products ? Catheter OcclusionJune 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 BolusJune 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 StaffJune 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...
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.
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.
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.
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.
“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, 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.
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.
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.
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 DiseaseJune 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 MarketJune 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. ...
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 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.
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.
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.
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.
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.