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St. Jude Medical Resolves FDA Warning Letter for Sylmar Facility

July 2, 2014 9:14 am | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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...

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FDA Leverages Big Data via Cloud Computing

June 23, 2014 3:58 pm | 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 | 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 | 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 | 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 | 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... 

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CDRH on Track to Improve Device Submission Review Process

June 13, 2014 2:00 pm | 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 | 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... 

Medtronic Heart Valve Approved for Broader Use

June 13, 2014 11:14 am | News | Comments

Medtronic Inc. said Thursday that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment. Medtronic's implant is a less invasive approach to...

FDA Releases First Phase of Global UDI Database

June 13, 2014 9:13 am | News | Comments

First phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry is now available. To quickly provide industry with information critical to successful use of the GUDID, we are issuing the GUDID Guidance in two...

Panel Provides Unanimous Favorable Recommendation to FDA for Bard's Drug Coated Balloon

June 12, 2014 8:28 pm | News | Comments

C. R. Bard, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB)...

Anti-Microbial Coatings with a Long-Term Effect for Surfaces

June 11, 2014 4:08 pm | News | Comments

Researchers at the INM – Leibniz Institute for New Materials have now produced antimicrobial abrasion-resistant coatings with both silver and copper colloids with a long-term effect that kill germs reliably and at the same time prevent germs becoming established. Hygienic conditions and sterile procedures are ...

TIA Encourages HHS Secretary to Examine Changes

June 11, 2014 11:51 am | News | Comments

The Telecommunications Industry Association, the association representing the manufacturers and suppliers of high-tech communications networks, joined a number of stakeholders in urging newly-confirmed Secretary of the Department of Health and Human Services Sylvia Burwell to take ...

First Patient Receives HeartAssist5 VAD Following CE Mark Approval

June 9, 2014 5:23 pm | News | Comments

Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, announced the first advanced stage heart failure patient received its next generation HeartAssist5 Ventricular Assist Device (VAD) since the company...

OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

June 2, 2014 3:48 pm | Blogs | Comments

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to...

Breaking Down the Regulation of LDTs

June 2, 2014 11:34 am | Blogs | Comments

I received a copy of 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 Combination Products...

Medtronic Launches Advisa and Ensura SR MRI SureScan Pacemaker Systems in Europe

June 2, 2014 10:22 am | News | Comments

Medtronic, Inc., today announced CE (Conformité Européenne) Mark and commercial launch of the Advisa and Ensura SR MRI SureScan single chamber pacemaker devices in Europe. Both pacemakers are approved for magnetic resonance imaging (MRI)...

Report on Medical Device Market Outlines Challenges, Opportunities for Cost Containment

May 30, 2014 3:44 pm | Admet, Inc. | Blogs | Comments

The medical device market has experienced tremendous growth, reaching more than $330 billion worldwide. While the industry remains healthy, several challenges face those who design and manufacture medical devices. ADMET serves this market...

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