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Verizon Gains FDA Clearance for Remote Health Monitoring Solution

August 8, 2013 4:15 pm | by PR Newswire | News | Comments

Verizon announced today that it has received U.S. Food and Drug Administration 510(k) clearance for Converged Health Management, a cloud-based, remote patient-monitoring medical device.  This marks the first time Verizon has sought and gained FDA clearance for a healthcare solution.

FDA Approves First Rapid Diagnostic Test to Detect both HIV-1 Antigen and HIV-1/2 Antibodies

August 8, 2013 3:13 pm | by Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens.

Cordis recall of Optease vena cava filter is Class I

August 8, 2013 12:01 pm | by Mass Device | News | Comments

The recall last March of Johnson & Johnson unit Cordis Corp.'s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death. Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.

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Presentations posted for Battery-Powered Medical Devices Workshop: Challenges and Opportunities, July 30-31, 2013

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

Batteries play a significant role in the overall safety, performance, and reliability of many life-saving and life-sustaining medical devices. As more medical devices become computerized, compact, and mobile, the number of battery-powered medical...

Class I Medical Device Recall: Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter

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

The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.

Hacking: FDA is developing a 'cybersecurity laboratory'

August 6, 2013 2:51 pm | by Mass Device | News | Comments

Medical device makers would do well to fortify their cybersecurity strategies in preparation for the extra layers of software testing and review in development at the FDA. Federal healthcare regulators have solicited bids from security group Codenomicon Defensics to help build a "cybersecurity laboratory" where regulators can take a closer look at software bugs and weaknesses in medtech systems.

Tips for Legacy Medical Device Submissions to 60601 3rd Edition Electrical Safety Testing

August 5, 2013 3:40 pm | by Vincent Crabtree, Ph.D., Project Manager, StarFish Medical | Blogs | Comments

In Part 1 of this blog, I described the background and approaches StarFish Medical employed for more modern devices with a comprehensive technical file, giving five top tips. In Part 2, I now describe how we recertified for older devices where the available design documentation was less comprehensive.

TAVI: Edwards wins FDA approval to begin clinical studies of next-gen Sapien 3 valve

August 5, 2013 12:29 pm | by Mass Device | News | Comments

Medical device giant Edwards Lifesciences is powering forward with its solo-hold on the U.S. market for transcatheter aortic valve implantation systems, now preparing to launch an Investigational Device Exemption clinical trial of its next-generation Sapien 3 TAVI device.

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Alere™ MobileLink Receives FDA Clearance

August 5, 2013 11:38 am | by PR Newswire | News | Comments

Alere Connect has been granted a 510(k) market clearance by the U.S. FDA for the Alere MobileLink.  The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.

Medical device tax repeal bill has 259 co-sponsors with more on the way

August 1, 2013 5:25 pm | by Mass Device | News | Comments

Representatives in the U.S. House are set to top last year's vote to repeal the 2.3% medical device excise tax. The "Protect Medical Innovation Act of 2013," co-sponsored by Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wis.), has garnered 259 signatures, according to the Library of Congress' THOMAS database.

Gap Analysis Techniques for Easy Medical Device 60601 3rd Edition Electrical Safety Testing

August 1, 2013 4:45 pm | by Vincent Crabtree, Ph.D., Project Manager, StarFish Medical | Blogs | Comments

In Part 1 of this blog, I’ll describe the background and approaches we at StarFish Medical took for more modern devices with a comprehensive technical file, with five top tips. In Part 2, I’ll describe how we recertified for older devices where the design documentation was less comprehensive, with seven top tips.

Ambio Health lands 510(k) for home-based patient monitoring and data sharing

August 1, 2013 3:29 pm | by Mass Device | News | Comments

Ambio Health scored a green light from the FDA for its Ambio Remote Health Monitoring System, passing muster as a Class II device, the same category as wheelchairs and infusion pumps. The at-home monitoring system is designed to keep tabs on vital signs for patients with high blood pressure, heart disease and diabetes.

Biopharmaceutical and Medical Device Associations Strongly Support Senate Bill to Exempt FDA User Fees from Sequestration

August 1, 2013 3:12 pm | by Business Wire | News | Comments

Today, Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration.

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Camera Crushes Patient; Sparks Recall

August 1, 2013 12:40 pm | by David Mantey, Executive Editor, MDT | News | Comments

This week, the U.S. Food and Drug Administration (FDA) announced the recall of GE Healthcare’s Nuclear Medicine Systems were recalled following an incident at a VA Medical Center in which a patient died due to injuries sustained while being scanned.

FDA considers patient preference on benefit-risk trade-offs in medical devices

July 30, 2013 1:29 pm | by Mass Device | News | Comments

The FDA is looking to make some updates to its medical device benefit-risk calculations, taking into greater consideration the preferences of patients, caregivers and healthcare workers. The federal watchdog agency is holding a public workshop to solicit suggestions on how its medical device review arm might better assess and incorporate patient perspectives on "meaningful benefits" and "appropriate risks" of new medical devices.

IntelligentMDx Receives FDA Clearance for IMDx VanR for Abbott m2000 assay

July 29, 2013 4:41 pm | by PR Newswire | News | Comments

IntelligentMDx (privately held) announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE).

Class I Medical Device Recall: GE Healthcare Nuclear Medicine Systems

July 29, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals...

Public Workshop - The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes, September 18-19, 2013

July 29, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this workshop is to discuss ways to incorporate patient preferences on the benefit-risk trade-offs of medical devices into the full spectrum of the Center for Devices and Radiological Heath (CDRH) regulatory decision making. It also aims...

Panasonic to Sell Part of Healthcare Business

July 26, 2013 11:49 am | by The Associated Press | News | Comments

Panasonic said Friday it will sell its ultrasonic diagnostic equipment business to Konica Minolta Inc. in January 2014 as part of efforts to improve its financial base eroded by the firm's recent sluggish performance.     

Teaching Old Drugs New Tricks

July 26, 2013 9:52 am | by Cambridge Consultants | News | Comments

Innovative product development and technology consultancy firm Cambridge Consultants has collaborated with Clinigen Group to create a new way of identifying fresh market applications for drugs nearing the end of their product lifecycle.

Cepheid Receives FDA Market Authorization for Xpert MTB/RIF

July 25, 2013 5:29 pm | by PR Newswire | News | Comments

Cepheid today announced it has received market authorization from the U.S. Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.

EnteroMedics Announces PMA Application for VBLOC Therapy in Obesity Accepted for Review and Filing by FDA

July 25, 2013 4:03 pm | by The Associated Press | News | Comments

EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the U.S. FDA has accepted for filing the Company's Premarket Approval application for approval of the Maestro® Rechargeable System's VBLOC® vagal blocking therapy as a treatment for obesity.

Johnson & Johnson subsidiary gets Class I recall for implantable infusion pumps

July 25, 2013 11:29 am | by Mass Device | News | Comments

The FDA puts its highest-risk label on a recall of programmable infusion pumps made by Codman & Shurtleff Inc., a division of Johnson & Johnson subsidiary DePuy Orthopaedics. Codman's implanted MedStream pumps were recalled over a potential defect in a component that measures the contents of the pump reservoir.

Best Practices for and Common Pitfalls in Creating Device Listing Files

July 24, 2013 2:32 pm | by Howard Shatz, SPL and ACA 6004 Project Manager, Data Conversion Laboratory | Articles | Comments

Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.

Addressing UDI Compliance with Direct Printing

July 23, 2013 5:10 pm | by Rachel Hammer, Product Manager, Roland DGA Corp. | Roland DGA Corporation | Blogs | Comments

As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.

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