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OpenFDA Provides Ready Access to Recall Data

July 17, 2014 3:01 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA | Blogs | Comments

Every year, hundreds of foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be...

FDA Approves Freedom Portable Driver for the SynCardia Total Artificial Heart

July 17, 2014 12:08 pm | by SynCardia | News | Comments

The Freedom portable driver received FDA approval on June 26, 2014 for use with the SynCardia temporary Total Artificial Heart as a bridge to transplantation in cardiac transplant candidates who are clinically stable. “With the FDA approval...

Developing New Tools to Support Regulatory Use of “Next Gen Sequencing” Data

July 15, 2014 3:00 pm | by Carolyn A. Wilson, Ph.D., Associate Director for Research Center for Biologics Evaluation and Research, FDA | Blogs | Comments

When you’re thirsty, you don’t want to take a drink from a fire hose. And when scientists are looking for data they don’t want to be knocked over with a flood of information that overwhelms their ability to analyze and make sense of it. That’s...

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Boston Scientific Receives CE Mark for TAVI System

July 15, 2014 8:51 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark and begun the European commercial launch of its new 25 mm Lotus Transcatheter Aortic Valve Implantation (TAVI) System, complementing the currently available 23 mm and 27 mm valve sizes... 

Boston Scientific Receives CE Mark for Ranger Drug-Coated Balloon

July 14, 2014 9:31 am | by PR Newswire | News | Comments

Demonstrating its continued leadership in the development of innovative solutions for peripheral vascular disease, Boston Scientific Corporation has received CE Mark for the Ranger Paclitaxel-Coated PTA Balloon Catheter. The technology is...

FDA Weighs Cancer Risk of Fibroid Removal Devices

July 14, 2014 9:18 am | by Matthew Perrone - AP Health Writer | News | Comments

Federal health advisers say there is little to no evidence that a popular technique for removing fibroids can be performed without the risk of spreading undetected cancers to other parts of the body. The panel of Food and Drug Administration...

FDASIA at Year Two

July 10, 2014 9:33 am | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law. To...

EarlySense Chair Sensor Receives FDA Clearance

July 7, 2014 3:09 pm | by PR Newswire | News | Comments

EarlySense, the market leader in contact free monitoring solutions, has announced the market clearance by the US Food and Drug Administration for the Chair Sensor Solution. The Chair Sensor, which continuously monitors patient's Heart Rate...

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Concern at Lack of Teenage Patients in Cancer Trials

July 7, 2014 1:45 pm | by Cancer Research UK | News | Comments

Age limits on clinical trials need to be more flexible to allow more teenage cancer patients the chance to access new treatments, according to a report from the National Cancer Research Institute (NCRI), published in the Lancet Oncology. The...

Empowering Consumers Through Accurate Genomic Tests

July 2, 2014 11:45 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab...

St. Jude Medical Resolves FDA Warning Letter for Sylmar Facility

July 2, 2014 9:14 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, announced that it has been notified by the U.S. Food and Drug Administration (FDA) that issues cited in the Sylmar, Calif., facility’s warning letter have been addressed. “We take...

Are Your Compliance Practices Cloud and Mobile Friendly?

July 1, 2014 3:23 pm | by Mika Javanainen, Senior Director of Product Management, M-Files Corporation | Blogs | Comments

The “bring your own device” (BYOD)-enabled workforce is altering the landscape of compliance-related content management. Medical device companies should take this trend seriously because if you implement your BYOD strategy well, it can have...

Filling Information Gaps for Women in Medical Device Clinical Trials

June 27, 2014 1:58 pm | by David Strauss, M.D., Ph.D., Medical Officer, Center for Devices and Radiological Health, FDA | Blogs | Comments

At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices — devices, such as implantable heart devices, that carry...

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Encision Receives FDA 510(k) Approval on its AEM EndoShieldT Burn Protection System

June 27, 2014 9:25 am | by The Associated Press | News | Comments

Encision Inc., a medical device company owning patented surgical technology that prevents dangerous stray electrosurgical burns in minimally invasive surgery, today announced that it has received FDA 510(k) premarket notification approval...

Redesigning Clinical Trials to Boost Participation

June 26, 2014 3:13 pm | by University of Michigan Health System | News | Comments

It’s a classic Catch-22: Medical researchers need to figure out if a promising new treatment is truly better than a current one, by randomly assigning half of a group of patients to get each treatment. But when they approach patients about...

Intuitive Surgical Receives CE Mark for the da Vinci Xi Surgical System

June 25, 2014 9:16 am | by Globe Newswire | News | Comments

Intuitive Surgical, Inc., the global leader in robotic-assisted minimally invasive surgery, today announced it has received a CE Mark for its da Vinci Xi Surgical System. Achieving this milestone allows the company to market the Xi System...

FDA Encourages Medical Device Data System Innovation

June 24, 2014 2:16 pm | by Bakul Patel, Senior Policy Advisor in Center for Devices and Radiological Health, FDA | Blogs | Comments

Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health. Some of these systems, referred to as “medical...

CE Mark for Abbott’s Extended Range of Vision Intraocular Lens for Cataract Patients

June 24, 2014 10:35 am | by Abbott | News | Comments

Abbott announced it has received CE Marking (Conformité Européenne) in Europe for the TECNIS Symfony Extended Range of Vision intraocular lens (IOL) for the treatment of cataract patients who may also have a diminished ability to focus...

FDA Leverages Big Data via Cloud Computing

June 23, 2014 3:58 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA | Blogs | Comments

Last year, I worked with a group of colleagues throughout the Food and Drug Administration (FDA) on a project that is critical for the agency’s future: the modernization of our information technology platforms to prepare for the influx of...

Breaking Down the Regulation of LDTs: FDA Authority

June 23, 2014 10:33 am | by Richard Park, Contributing Editor | Blogs | Comments

During the past couple of weeks, I’ve been reporting on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter...

FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products

June 18, 2014 2:27 pm | by Thomas Abrams, Director – Office of Prescription Drug Promotion, CDER, FDA | Blogs | Comments

Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients...

Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis

June 17, 2014 9:50 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

At FDA’s medical devices center, we have a vision — it’s what we strive for each day in our review and assessment of new medical technology. And patients are at the very core of that vision: “Patients in the U.S. have access to high-quality...

How to Market Your Device

June 16, 2014 9:34 am | by U.S. Food & Drug Administration | News | Comments

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299... 

CDRH on Track to Improve Device Submission Review Process

June 13, 2014 2:00 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

FDA’s Center for Devices and Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access...

Breaking Down the Regulation of LDTs: FDA Jurisdiction

June 13, 2014 1:54 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, I reported on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the... 

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