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CEA Joins Industry Groups in Sponsoring Educational Series on Health App Development Under FDA Regulation

January 17, 2014 11:53 am | by Consumer Electronics Association | News | Comments

Today, the Consumer Electronics Association announced its sponsorship of an educational program series called the “Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation,” joining a consortium of six leading... 

Direct Part Marking for UDI Needs

January 16, 2014 3:01 pm | by Gerry Gunderson, CPP, VP of Engineering, Quality Tech Services | Quality Tech Services, Inc. | Blogs | Comments

The Final Rule for FDA’s Unique Device Identification (UDI) mandate is now released and will be in focus in 2014. Class III device manufacturers will need to comply by September 2014, unless granted an exception (and excluding grandfathered...

Google gets in hot water over targeted healthcare ads

January 16, 2014 7:29 am | by Mass Device | News | Comments

Internet and technology giant Google agreed to overhaul its healthcare-related advertising practices after Canadian regulators accused the company of violating privacy laws by using search histories to target users with healthcare-related...

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FDA dings Philips on InnerCool RTx component recall

January 15, 2014 5:09 pm | by Mass Device | News | Comments

The FDA dinged Philips for tardiness in its notification of the recall of a component for its InnerCool RTx body temperature control device in a warning letter sent last month. Philips issued a recall in January 2012 of the main control board for the...

AdvaMed Applauds Restoration of FDA User Fees in Appropriations Bill

January 15, 2014 12:22 pm | by AdvaMed | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today following the release of the federal government’s fiscal year 2014 omnibus appropriations legislation. “AdvaMed...

Evaluation of Automatic Class III Designation (De Novo) Summaries

January 15, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving...

USP <1115>—Bioburden Control of Nonsterile Drug Substances and Products

January 14, 2014 1:40 pm | by Jonathan Swenson, Microbiology Department Manager, B.S., RM (NRCM), Nelson Labs | Nelson Laboratories, Inc. | Blogs | Comments

The control of microorganisms when manufacturing products that are nonsterile is an ongoing challenge. Since the products are intended to be “nonsterile,” there is an inherent acceptance that organisms may be present in the product; however...

FDA mandates pediatric data requirements for new medtech applications

January 13, 2014 6:38 pm | by Mass Device | News | Comments

The FDA this month finalized a rule requiring more pediatric patient information from medical devices going through the premarket approval pathway, even if the products are intended for adults. The requirement, part of the Food & Drug...

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3 Major Trends in Barcode Labeling for Medical Devices

January 13, 2014 2:23 pm | by Nick Recht, Enterprise Product Manager, TEKLYNX Americas | Articles | Comments

Three major trends are flowing through the medical device industry, promoting patient safety and implementing positive changes. How will these trends affect your labeling processes? They will change the way you label product, help minimize...

Absorbable Vascular Stents Are Subject of New Surgical Devices Standard

January 13, 2014 11:50 am | by ASTM International | News | Comments

Patients with blockages in their coronary vasculature have historically been treated with permanent metallic stents, metal mesh tubes that open clogged blood vessels, restore blood flow and keep the vessel open over time. Certain patients...

MolecularHealth Registers for Medical Device Accreditation in Germany

January 13, 2014 9:00 am | by The Associated Press | News | Comments

MolecularHealth GmbH, the European arm of MolecularHealth, announced today that it formally started the registration of its proprietary oncology treatment decision support software as a medical device with DIMDI, the German Institute of Medical...

Is Google working on a medical device?

January 10, 2014 2:46 pm | by Mass Device | News | Comments

FDA medtech officials met last month with members of Google's clandestine "X" research team, raising speculations about a foray into medical devices for the group that was behind Google Glass and the company's self-driving car. A quartet of...

Setting the Bar for Blood Glucose Meter Performance

January 10, 2014 2:34 pm | by Courtney Lias, Director, Division of Chemistry and Toxicology Devices, CDRH | Blogs | Comments

Many of the nearly 19 million Americans diagnosed with diabetes must monitor their blood glucose (sugar) frequently throughout the day using an at-home meter to make sure that their blood glucose is within a safe range. The ability to measure...

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CareFusion to Pay $40.1M in False Claims Case

January 10, 2014 10:43 am | by The Associated Press | News | Comments

CareFusion Corp. has agreed to pay $40.1 million to settle allegations it paid kickbacks and promoted its medical technology products for uses not approved by the Food and Drug Administration. The Justice Department announced the settlement...

Class I Medical Device Recall: Covidien, Puritan Bennett 840 Series Ventilator - Software Problem

January 9, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices...

Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 letter added)

January 9, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving...

SkinRex issued FDA warning letter

January 8, 2014 12:36 pm | by Mass Device | News | Comments

Korean cosmetic medical device company SkinRex Co. is in hot water with the FDA after the federal watchdog agency issued a warning letter over the marketing of its Cavi-Lipo device. Seoul-based Skinrex is focused on skincare and weight issues...

VeriTeQ Endorses England’s Decision to Launch Breast Implant Registry to Track Procedures and Devices

January 8, 2014 8:30 am | by The Associated Press | News | Comments

VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, announced today that a new breast implant registry will be launched in England beginning early this year to track breast...

FDA Reclassifies ECP Devices for Refractory Angina as Class II

January 6, 2014 4:25 pm | by PR Newswire | News | Comments

Vasomedical, Inc., a diversified medical technology company specializing in the design, manufacture and sale of medical devices including EECP® (Enhanced External Counterpulsation) Therapy systems, the gold standard of ECP therapy, announced...

Driving Innovation Is a Key Part of Our Mission

January 6, 2014 2:43 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA’s responsibility to protect the public health – and always will be. But what is often lost or neglected...

Class I Medical Device Recall: GE Healthcare, LLC - Multi Absorber Original, Disposable - Model M1173310

January 6, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Multi Asborber, Original may have a thin wall condition, which may lead to small holes in the water (drain) tube. This may result in loss of anesthetic gases, ventilations and oxygenation. This product may cause serious adverse health...

Get to Know IEC60601-1 3rd Edition Before Selecting Your Medical Power Supply

January 3, 2014 1:15 pm | by Jay vanWormer, Murata Power Solutions | Murata Power Solutions | Articles | Comments

Standards and their implementation can often cause a lot of confusion, and the 3rd edition of the medical safety standard IEC60601-1 is no exception. Initially ratified as early as 2005, it has only been since the recent withdrawal of the...

FDA shifts regulatory requirements for intra-aortic balloons

January 3, 2014 12:52 pm | by Mass Device | News | Comments

The FDA issued a final rule reclassifying certain intra-aortic balloons and demanding more from others, according to a notice in the Federal Register. The new rule eases regulation on intra-aortic balloons and pumps indicated for acute... 

510(k) Submission Process

January 3, 2014 12:00 am | by U.S. Food & Drug Administration | News | Comments

Premarket Notification (510(k)) submissions for medical devices are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological...

Robotic surgery complaints become FDA complaints

January 2, 2014 5:05 pm | by Mass Device | News | Comments

As patient complaints mount in lawsuits against Intuitive Surgical and its da Vinci robot-assisted surgical platform, physicians and researchers are shifting some of the blame to the FDA's postmarket surveillance systems as an inadequate...

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