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Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

August 20, 2014 2:03 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. Section 907 of the...

Providing Easy Access to Medical Device Reports Submitted to FDA Since the Early 1990s

August 19, 2014 2:06 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA and Jeffrey Shuren, M.D., Director – CDRH, FDA | Blogs | Comments

In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical...

3D Printed Patient-Specific Facial Device Receives FDA Clearance

August 19, 2014 11:26 am | by Globe Newswire | News | Comments

Oxford Performance Materials, Inc., a leading advanced materials and additive manufacturing (3D...

Patent examiners more likely to approve marginal inventions when pressed for time

August 13, 2014 4:02 pm | by EurekAlert! | News | Comments

Haste makes waste, as the old saying goes. And according to research from a University of...

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Photos of the Day: Counterfeiting's Breathalyzer

August 7, 2014 4:45 pm | by University of Michigan | News | Comments

Terry Shyu, a doctoral student in chemical engineering at the University of Michigan, was demonstrating a new high-tech label for fighting drug counterfeiting. While the researchers don't envision movie stars on medicine bottles, but they...

A Breath Reveals a Hidden Image in Anti-Counterfeit Labels

August 7, 2014 4:45 pm | by University of Michigan | News | Comments

An outline of Marilyn Monroe's iconic face appeared on the clear, plastic film when a researcher fogs it with her breath. Terry Shyu, a doctoral student in chemical engineering at the University of Michigan, was demonstrating a new high-tech...

FDA Approval for Medtronic’s Attain Performa Quadripolar Lead and Viva Quad CRT-Ds

August 7, 2014 9:47 am | by Medtronic | News | Comments

Medtronic, Inc. has announced it has received United States Food and Drug Administration (FDA) approval for the Attain Performa Model 4298 quadripolar lead, and the Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators...

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UDI: A Nonstandardized Test for Manufacturers

August 5, 2014 4:23 pm | by Karen Conway, Executive Director, Industry Relations, GHX | Blogs | Comments

The underlying purpose of the U.S. FDA’s Unique Device Identification (UDI) Rule seems simple enough: to “adequately identify medical devices through distribution and use.” But even manufacturers that have been working for years – some even...

Curbing Risk, Not Medical Innovation, in Personalized Medicine

August 4, 2014 3:55 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

Innovative new tests are routinely submitted to the Food and Drug Administration to assure they are safe and effective. They include genetic tests that help oncologists decide whether a patient is a good candidate for a drug that treats melanoma...

Breaking Down the Regulation of LDTs: Moving Forward

August 4, 2014 3:29 pm | by Richard Park, Contributing Editor | Blogs | Comments

The letter stated that in order to move toward equal regulation, FDA should share its thinking on what it believes LDT regulation under FDCA should look like in practice, or how it plans to deregulate IVDs, by releasing its draft guidance...

FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests

August 4, 2014 8:20 am | by FDA | News | Comments

The U.S. Food and Drug Administration has taken important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results. First, the FDA is issuing a final...

Test To Screen Donors of Blood, Tissues, and Organs for Hepatitis E Virus Receives CE Mark

July 24, 2014 2:27 pm | by Grifols | News | Comments

Grifols, one of the world’s leading companies in the plasma-derived biological medicines and transfusion medicine sectors, has announced CE mark for the Procleix HEV assay. The test, developed in collaboration with Hologic, Inc. (HOLX)...

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A Curriculum for Medical Device Progress

July 22, 2014 3:44 pm | by Francis Kalush, Ph.D., senior science advisor, Center for Devices and Radiological Health, FDA | Blogs | Comments

Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in the groves of Academe” — and in the last four years, my colleagues in FDA’s Center for Devices and Radiological Health (CDRH) and I took his advice. In...

Two UL Battery Safety Standards Are Now FDA Recognized Consensus Standards for Medical Devices

July 22, 2014 9:18 am | by PR Newswire | News | Comments

UL (Underwriters Laboratories), a global safety science leader, has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium...

FDA Approval for Boston Scientific’s REBEL Platinum Chromium Coronary Stent System

July 22, 2014 9:06 am | by PRNewswire | News | Comments

Boston Scientific Corporation has received FDA approval for the REBEL Platinum Chromium Coronary Stent System, the company's latest generation bare-metal stent for the treatment of coronary artery disease (CAD). Bare-metal stents continue...

FDA 510(k) Clearance for Varian Medical Systems’ Calypso Soft Tissue Beacon Transponder

July 21, 2014 10:18 am | by PR Newswire | News | Comments

Varian Medical Systems today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a Calypso soft tissue Beacon transponder that can help enhance the precision of radiotherapy and radiosurgery...

FDA Clearance for Expanding Orthopedics’ Flxfit 3D Expandable Interbody Cage

July 21, 2014 10:17 am | by PR Newswire | News | Comments

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgeries, is excited to announce that its FLXfit, the world's first 3D expandable...

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Breaking Down the Regulation of LDTs: Access to Innovative IVDs

July 21, 2014 9:10 am | by Richard Park, Contributing Editor | Blogs | Comments

During the past few 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 on behalf...

‘International Clinical Trial Rescue’ Program for Medical Devices

July 18, 2014 11:40 am | by Factory CRO | News | Comments

Factory CRO has announced a new, early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators. “Because...

Dreamit Health Philadelphia Announces Its Next Cohort of MedTech Startups

July 18, 2014 11:20 am | by Dreamit Health | News | Comments

Independence Blue Cross (Independence), Penn Medicine, and DreamIt Ventures today announce the cohort of nine health-tech startups selected to participate in DreamIt Health Philadelphia 2014, the third cycle of DreamIt’s health-tech accelerator...

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...

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...

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...

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