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Samsung Aims to Be Top Medical Device Maker

November 6, 2013 10:38 am | by Youkyung Lee, AP Technology Writer | News | Comments

Samsung wants to be the top medical device maker through acquiring companies and developing its own technologies. In the last three years, Samsung spent $1 billion to buy 14 companies in medical equipment, mobile software and services ...

Testosterone Treatments Linked to Heart Risks

November 6, 2013 10:18 am | by Lindsey Tanner, AP Medical Writer | News | Comments

Testosterone treatments may increase risks for heart attacks, strokes and death in older men with low hormone levels and other health problems, a big Veterans Affairs study suggests. The results raise concerns about ...     

RFID Chips for Breast Implants

November 1, 2013 10:45 am | by Business Wire | News | Comments

VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, has announced that it has delivered its first order of 2,000 Q Inside Safety Technology radio frequency identification...

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U.S. FDA shares more details on MDSAP international audit pilot

October 28, 2013 3:47 pm | by Mass Device | News | Comments

Following the Australian Therapeutic Goods Administration’s recent news that Australia, Brazil, Canada and the US will launch a pilot for the Medical Device Single Audit Program (MDSAP) for medical devices in January 2014, The US Food and Drug... 

Boston Scientific Receives CE Mark for Lotus Valve System

October 28, 2013 2:09 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark for the Lotus™ Valve System, the company's advanced transcatheter aortic valve replacement (TAVR) technology.  This key approval offers a unique and effective new treatment alternative for...

Animal-Derived Component Free Molding for Medical Devices

October 25, 2013 3:38 pm | by David Johnson, Engineering Manager; Steve Fischer, Senior Manufacturing Engineer; Ryan Fuhr, Senior Manufacturing Engineer; Sven Nelson, Project Manager; and John Haley, VP of Operations | Advanced Molding Technology | Blogs | Comments

A group of representatives from Advanced Molding Technologies was a part of the staff written article, “Molders Address Biggest Device Issues.” They took time to present an array of responses that were not all able to be included in the article...

Lasers Offer an Automated Way to Test Drinking Water

October 22, 2013 10:17 am | by Fraunhofer-Gesellschaft | News | Comments

To keep drinking water clean, experts are constantly monitoring our supply to check it for contaminants. Now laser technology will give them a helping hand: a new system automatically analyzes water samples at the waterworks itself. In today’s world, we simply cannot ...

Shutdown ends, FDA user fees begin

October 17, 2013 4:10 pm | by Mass Device | News | Comments

The FDA can begin collecting user fees from medical device companies for fiscal 2014 now that the federal shutdown is over. The watchdog agency announced new rates for the fees in August, but couldn't begin collecting them when the fiscal year...

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2014 User Fees

October 16, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Information regarding MDUFA III fees. Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR or BLA.                                

How Will Proposed ISO 10993-1 Change Impact Your Biocompatibility Plans?

October 15, 2013 3:42 pm | by Mark Drlik, Mechanical Engineer and Project Manager, StarFish Medical | Blogs | Comments

Document UCM348890 (FDA’s April 2013 proposal to change the guidance document for ISO 10993-1) seems pretty straight forward—with things like testing details associated with genotoxicity and how to go about labeling your device as “BPA-free”...

FDA Advisory Panel Recommends Expanded Indication for Medtronic's CRT Devices

October 8, 2013 6:06 pm | by The Associated Press | News | Comments

The U.S. Food and Drug Administration's (FDA) Circulatory Systems Devices Advisory Panel today voted that biventricular (BiV) pacing with Medtronic, Inc. (NYSE: MDT) devices is beneficial for treating patients who have atrioventricular (AV) block...

The FDA’s UDI Rule is Final! What Now?

October 8, 2013 12:02 pm | by Ken Koldan, Business Development Manager, FLEXcon | Blogs | Comments

The FDA published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed.

BREAKING: House votes to fund FDA past shutdown

October 7, 2013 7:18 pm | by Mass Device | News | Comments

The U.S. House of Representatives voted tonight to fund the FDA until the federal shutdown ends or until Dec. 15, whichever comes first. The lower chamber approved on a 235-162 vote a joint resolution by Rep. Robert Aderholt (R-Ala.) that restores funding to the level established by sequestration, which is about $200 million less than originally authorized.

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Don’t Need a Cleaning and Disinfection Validation? Check Again!

October 7, 2013 3:59 pm | by Mike Neilson, Section Leader, Healthcare Reprocessing, BS, RM (NRCM) CQPA (ASQ) | Nelson Laboratories, Inc. | Blogs | Comments

When you hear the term “reusable medical devices,” you may think of surgical instruments like forceps or scissors. Reusable devices often have intimate patient contact, become grossly soiled during use, and need to be reprocessed before their next use.

FDA Shutdown Could Cause Major Delays to Heart Failure Device Approvals

October 7, 2013 10:33 am | by GlobalData | News | Comments

The recent government shutdown will significantly impact upon FDA services and operations, especially in the heart failure (HF) and arrhythmia markets, due to the agency’s limited proactive abilities for device approvals, according to an analyst with research and consulting firm GlobalData.

Evaluating FDA Guidance for RF Wireless Technology in Medical Devices

October 7, 2013 8:55 am | by Kenneth MacCallum, PEng, Principal Engineering Physicist, Starfish Medical | Blogs | Comments

Last month, the FDA issued a guidance document for RF wireless technology in medical devices. Not surprisingly, the FDA is recommending a risk-based approach to design, testing, deployment, and maintenance of medical device development. This follows the risk-based approach to safety that was introduced in the 3rd edition of 60601-1.

GE Healthcare lands EU approval for Vivid E9 ultrasound

October 4, 2013 11:29 am | by Mass Device | News | Comments

Medical technology giant GE Healthcare won European regulatory approval for the latest in its line of Vivid E9 ultrasound systems with XDclear technology. The next-generation system with XDclear features enhanced image quality in 2D, 4D, color and Doppler, tools that can help with hard-to-image patients, including those who are obese.

Delivering Clarity on FDA’s Updates to mHealth and Wireless Guidelines

October 4, 2013 9:58 am | by The Technology Partnership | News | Comments

Last week the FDA's mHealth guidance was published in its final form, after being in draft status since 2011. This marks significant progress in developing opportunities for mHealth and connected medical services and follows publication of supporting technical recommendations on wireless and mHealth technologies for use in medical devices in August and September this year.

FDA meeting sacrificed to government shutdown

October 3, 2013 9:29 am | by Mass Device | News | Comments

Medical device makers will have to wait a little longer for progress on implementation of the FDA's Safety & Innovation Act, now that a meeting with a Senate Health, Education, Labor & Pensions committee has been canceled amid the federal government shutdown.

What's changing, what's not, in a shutdown

October 1, 2013 3:38 am | by Calvin Woodward - Associated Press | News | Comments

Campers in national parks are to pull up stakes and leave, some veterans waiting to have disability benefits approved will have to cool their heels even longer, many routine food inspections will be suspended and panda-cams will go dark at the shuttered National Zoo.

CareFusion Provides Update On Voluntary Recall Of AVEA® Ventilator

September 30, 2013 4:16 pm | by PR Newswire | News | Comments

The company initiated the voluntary recall on Sept. 3, 2013. The FDA has classified this action as a Class I recall. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed Devices

September 30, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation, discussed today a new market opportunity for identifying breast implant sizers, which was created, in part, by the FDA Final Rule for Unique Device Identification, announced on September 20, 2013.

QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

September 26, 2013 2:13 pm | by Business Wire | News | Comments

On Friday, September 20, the final Unique Device Identification (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement.

FDA Broadens Options for Using Edwards Heart Valve

September 24, 2013 11:45 am | by The Associated Press | News | Comments

The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways. The agency approved revised labeling for Edwards Lifesciences' Sapien heart valve...

FDA Lays Out Rules for Some Smartphone Health Apps

September 24, 2013 11:38 am | by The Associated Press | News | Comments

Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy.

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