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FDA Approves Over-the-Counter Blood Glucose Meter

April 17, 2015 2:27 pm | by Abbott Laboratories | News | Comments

The cost of insurance premiums and employee medical claims continues to rise in the United States, which is especially challenging for people living with chronic conditions such as diabetes. For people with diagnosed diabetes, average, direct...

FDA and CMS Form Task Force on LDT Quality Requirements

April 17, 2015 12:15 pm | by Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc | Blogs | Comments

Health care providers and their patients expect that laboratory tests used in clinical...

FDA Finalizes Program to Speed Access to Devices for Gravely Ill Patients

April 15, 2015 10:02 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) has introduced a program intended to give gravely...

World's Smallest Pacemaker Receives CE Mark

April 14, 2015 10:54 am | by Medtronic | News | Comments

Medtronic plc today announced it has received CE (Conformité Européenne) Mark of the Micra...

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3 Keys to Medical Device Development Excellence

April 13, 2015 11:29 am | by Mohan Ponnudurai, Industry Solution Director, Sparta Systems, Inc. | Articles | Comments

Some of the future-looking technological developments in medicine, including surgeries enabled by virtual reality, remote surgery, needle free treatments and even electronic aspirin, all have the same mission in mind – to deliver the highest level...

Developing a Do-It-Yourself-Pancreas

April 10, 2015 8:30 am | by Charles Settles, Product Analyst, TechnologyAdvice | Blogs | Comments

Diabetes, the seventh leading cause of death in the U.S., receives the 37th-most research funding, according to the NIH. Seeing little progress, some diabetics are taking matters into their own hands. Health IT is one of the fastest growing...

Providing Timely Patient Access to High-Quality, Safe and Effective Medical Devices

April 9, 2015 11:19 am | by Jeffrey Shuren, M.D., J.D. | Blogs | Comments

We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may...

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Top 10 Patient Safety Concerns for Healthcare Organizations

April 7, 2015 8:54 am | by ECRI Institute | News | Comments

Patient safety is a top priority for every healthcare organization, but knowing where to direct initiatives can be daunting. To help organizations decide where to focus their efforts, ECRI Institute has compiled its second annual list of the...

EMR and EHR: Orienting the Focus

April 7, 2015 8:30 am | by Zev Ginzburg, UX Researcher & Copywriter, Codal Inc. | Blogs | Comments

The EHR and EMR mandates in the Patient Protection and Affordable Health Care Act (PPACA) provisions in conjunction with the Health Information Technology for Economic and Clinical Health Act (HITECH) create noticeable fiscal incentives...

Medical Device Maker Settles Lawsuit for $4.4 Million

April 6, 2015 10:24 am | by The Associated Press | News | Comments

Medtronic has agreed to pay $4.4 million to settle a lawsuit filed by the federal government accusing the company of selling medical devices made in China and Malaysia to the U.S. military. Federal law requires that devices sold to the military...

Achieving UDI Compliance & Reducing Print Time

April 2, 2015 3:40 pm | by Josh Roffman, Vice President of Marketing & Product Management, Loftware | Articles | Comments

Founded more than 30 years ago in Switzerland, EMS Electro Medical Systems is a manufacturer of micromechanical instruments. Specializing in the design and development of orthopedic, urological and dental prophylaxis devices, the company...

3 Tips for Managing Your Medical Device Design History File

March 31, 2015 8:30 am | by Jon Speer, Co-Founder & VP of QA/RA, greenlight.guru | Blogs | Comments

Developing a cutting edge medical device can be really fun and exciting. There’s always something to test and do and learn from. You have that great feeling you’re changing the world. Documenting the development of a medical device isn't fun...

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FDA Approves Blood Pump System for High-Risk Cardiac Procedures

March 28, 2015 8:30 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention...

Organ Printing, Regulation in the Spotlight on MDT Live

March 27, 2015 3:39 pm | by Megan Crouse, Real Time Digital Reporter, @abmdigi | Articles | Comments

3D printing for medical devices is still a wild frontier without thorough regulation, which can both make building a product difficult and can spur innovation. Three experts sat down with Editor-in-Chief Sean Fenske this week to talk about...

Laws That Kill Innovation Will Ultimately Kill People

March 27, 2015 2:02 pm | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Blogs | Comments

February 2014 can be defined by updated DFA proposals supporting updated standards specific to blood glucose monitor accuracy standards for devices used in both home consumer and healthcare facilities. Twelve months later, February 2015 is...

Maker of Tainted Medical Scopes Issues New Cleaning Guide

March 27, 2015 1:40 pm | by The Associated Press | News | Comments

The maker of medical scopes that have been linked to two recent "superbug" outbreaks at California hospitals has issued new cleaning instructions for the devices amid scrutiny from regulators, lawmakers and medical professionals. Olympus...

6 Mantras for Medical Device Manufacturers

March 27, 2015 11:32 am | by Bart Reitter, Director, QAD Life Sciences | Articles | Comments

If the physician’s maxim is Primum non nocere – first, do no harm – then a similar phrase can be applied to medical device manufacturers: produce safe, high-quality products with a reasonable return on investment. Lengthier and less succinct...

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Lawmaker Questions Maker of Scopes Tied to 'Superbug' Issues

March 26, 2015 1:45 pm | by Matthew Perrone, AP Health Writer | News | Comments

A federal lawmaker is seeking details from the manufacturer of medical scopes that have been linked to several "superbug" bacteria outbreaks at U.S. hospitals, increasing pressure on the company. U.S. Rep. Ted Lieu, D-Calif., wants to know...

Don't Forget About Patient Isolation to Ensure Safety

March 26, 2015 8:30 am | by Daniel Ruth, Medical Team Leader, TUV Rheinland | Blogs | Comments

The IEC 60601-1 standard for basic safety and essential performance of medical devices deals with many functional issues. They are typically addressed by manufacturers in their risk management files to ensure the device does not harm the...

The Challenge of ‘Big Data’ in Healthcare

March 25, 2015 10:01 am | by AAMI | News | Comments

Aviation and other sectors have been harnessing the power of big data for years. As a result, these industries have witnessed improved safety, finding a way to turn such data into valuable knowledge that can guide decisions and strategies...

Understanding Differences in 'Reprocessing Guidance for Industry and FDA Staff'

March 24, 2015 11:26 am | by Emily Mitzel, B.S. M.S. RM (NRCM), Healthcare Reprocessing Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Blogs | Comments

The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance. Based on the content and addition of Appendix E, this...

7 Criteria to Improve Reprocessed Medical Device Instructions

March 23, 2015 10:59 am | by Emily Mitzel, Consulting Manager; Alpa Patel, Senior Scientist; and Nick Workman, Study Director; Nelson Laboratories | Nelson Laboratories, Inc. | Articles | Comments

When it comes to the reprocessing of medical devices in the healthcare facility, simple is better. For decades, reusable medical devices have been used to enhance the health and well-being of patients undergoing medical procedures. Reprocessed...

6 Considerations When Implementing Agile in Medical Device Development

March 23, 2015 10:18 am | by Heidi Giesbrecht, MEng, Project Manager, StarFish Medical | Blogs | Comments

The benefits of Agile include improved quality, more opportunities for midcourse corrections, improved customer or business satisfaction, better alignment between business and IT and improved time to market,” according to a Forrester Research...

Medical Device Tax Repeal Included in Senate Republican Budget

March 23, 2015 9:42 am | by The United States Senate Committee on Finance | News | Comments

Finance Committee Chairman Orrin Hatch (R-Utah) and U.S. Senator Pat Toomey, (R-Pa.), a member of the Committee, praised the inclusion of the medical device tax repeal in the Senate Republican budget. Under Patient Protection and Affordable...

FDA Approves MRI-Safe Pacemaker

March 23, 2015 9:37 am | by The Associated Press | News | Comments

BIOTRONIK, a manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved its ProMRI Eluna pacemaker system. BIOTRONIK ProMRI technology allows patients to undergo full-body magnetic...

FDA Hosting Public Workshop On Device Risk in Postmarket Setting

March 23, 2015 8:38 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) is hosting a public workshop next month on the clinical considerations of risk with a medical device that is already on the market and in use. The agency says it wants to hear from all stakeholders...

Safe Power for Medical Devices Used at Home

March 20, 2015 11:25 am | by Diane Cupples, Vice President of Marketing, Schurter Inc. | Schurter, Inc. | Articles | Comments

An aging population and the rising cost of healthcare around the world are a matter of concern to the general public these days. This is especially true in the U.S.A., where keeping costs under control becomes more and more challenging. In order...

FDA Focuses on Reprocessing Instructions in New Guidance

March 20, 2015 9:00 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) has finalized guidance that includes recommendations for writing clear reprocessing instructions for reusable medical devices. The document comes at a time of heightened interest in the sterility of...

No One Risk Applies to All Devices

March 20, 2015 8:46 am | by Steven W. Badelt, Ph.D., Director of Outreach, Healthcare Working Group, INCOSE | Blogs | Comments

Medical device companies sometimes fail to follow a robust risk identification process. That process can neglect the risks that emerge when a device is integrated into the larger healthcare system. There is no one risk that applies to all...

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