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Trust, But Verify In Order to Comply with UDI

December 5, 2014 7:30 am | by Steve Cochran, Chief Technology Officer, GHX | Blogs | Comments

“Trust, but verify” is my advice to manufacturers seeking to comply with the UDI rule. As a third party submitter that has successfully loaded data into the Global UDI Database (GUDID), I can confidently tell manufacturers, "trust that it...

Develop an Internal Team for UDI

December 4, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Blogs | Comments

Working with industry, we still see a need for more internal conversations among various stakeholders within organizations for an effective rollout of UDI. This is because the regulation has “amended” many existing regulations that will impact...

Green Light from FDA for CT Lung-Imaging Software

December 3, 2014 11:08 am | by University of Michigan Health System | News | Comments

A technology that started in a University of Michigan Medical School lab may soon help lung disease patients around the world breathe a little easier, by helping their doctors make a clearer diagnosis and more individualized treatment plan. Imbio...

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Roll-Out UDI to the Device Manufacturer and Supply-Chain Partners

December 3, 2014 7:30 am | by Matt Kelly, Key Account Manager, Medical, Watlow | Blogs | Comments

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of...

Have A Solid Team in Place for UDI Compliance

December 2, 2014 7:30 am | by Linda Chatwin, Esq, RAC Manager, Medical Regulatory Advisory Services North America, Life and Health, UL LLC | Blogs | Comments

Preparing for UDI requires a well-thought through project plan. Someone in the organization needs to own the project and manage it carefully, or bring in outside resources to help. The key to success lies in examining current labeling processes...

Survey: UDI Compliance Poses Significant Challenge

December 1, 2014 10:37 am | by PRISYM ID | News | Comments

A recent survey of medical companies in Europe and North America has identified some of the key issues for packaging and labeling operations in the complex and changing medical device market. The survey, carried out by PRISYM ID, a leading...

Lab Group Hires Lawyers for LDT Fight

December 1, 2014 9:23 am | by Richard Park, Contributing Editor | Blogs | Comments

The American Clinical Laboratory Association (ACLA) has retained former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl M. Loeb University Professor and Professor of Constitutional Law at Harvard University...

Can Public-Private Partnerships Change the Healthcare Game?

November 26, 2014 1:49 pm | by TEDMED | Videos | Comments

The healthcare world is an ever-evolving area with countless stakeholders, all working towards improving the health of the population. But with different priorities and different ways of working, how can diverse stakeholders work together most effectively?...

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A MedTech Thanksgiving Tale

November 26, 2014 8:30 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Not so long ago, the collective nations of the medtech Native Americans co-existed in relative peace in a land far from all others. Sure, there was the occasional squabble between tribes, while other times, one tribe would absorb a smaller tribe into...

Cancer Device Gets Stronger Warning from FDA

November 24, 2014 11:58 am | by The Associated Press | News | Comments

U.S. regulators have strengthened their warning against use of a once-popular device for gynecologic surgery that can spread unsuspected cancer, saying its risk is only justified in a fraction of patients. The Food and Drug Administration is updating...

Converging Medical Device, Drug, and Biotech Companies

November 21, 2014 7:30 am | by Michael Drues, Founder & President, Vascular Sciences | Blogs | Comments

Most device development is evolutionary, (i.e., come out with one device, tweak it a bit to make a new device, etc.) I understand the advantages of evolutionary device development from a technology perspective, from a business perspective...

Working More Closely With Hospital Systems and Payers

November 20, 2014 7:30 am | by Michael Pereira, Senior Vice President of Technology & Operations, Ximedica | Ximedica | Blogs | Comments

Innovations are occurring from multiple paths, all fueled from a consumerization of the medical industry. Our expectations as patients, or as clinicians, or even as payers are changing what is acceptable coming from the medical device industry...

Preventing and Reducing Hospital Admissions

November 19, 2014 7:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Blogs | Comments

We are beginning to see more integration of capabilities in order to provide imaging, diagnostics, and tissue manipulation within a single device and procedure. This allows the clinician, after confirming suspicious tissue, to biopsy, ablate...

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Search History for 'Lessons Learned'

November 18, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Blogs | Comments

Increased quality and regulatory oversight, increased demand from an aging population and reduced reimbursements are realities for medical device companies. The Medical Device industry will have to focus on reducing costs in the product...

Assessing the Good and the Bad in the LDT Guidances

November 17, 2014 2:35 pm | by Richard Park, Contributing Editor | Blogs | Comments

FDA recently released two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances, the agency...

4 Questions to Ask when Considering the Cloud ERP Solution

November 12, 2014 7:30 am | by Bart Reitter, Director, QAD Life Sciences | Blogs | Comments

As a Medical Device manufacturer, you’ve undoubtedly heard and read the buzz about the cloud. The cloud, by definition, is a nebulous term that gets bandied about frequently these days. A simple definition of the Cloud is that it is a network...

ISO 80369 Standards on Small-Bore Tubing Connectors Inch Forward Toward Release

November 10, 2014 7:30 am | by Kyle Steele, New Product Development Engineer, Value Plastics | Value Plastics, A Nordson Company | Articles | Comments

The Luer connector has, for decades, been one of the most common types of small-bore (less than 8.5mm) connectors used in hospitals and other healthcare facilities to link or join medical devices, components, and accessories for the purpose...

Will ‘Outsiders’ Overtake the Medical Device Industry?

November 6, 2014 4:37 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

The real variable that makes companies like Google and Apple a threat to the more established medical device players (well, besides a big bankroll) is the experience and mindset they have. These are consumer companies who have been extremely...

Developing Devices for Disabled Patients with FDA Encouragement

November 4, 2014 2:15 pm | by William Maisel, M.D., M.P.H., Deputy Center Director for Science, FDA, and Chief Scientist CDRH | Blogs | Comments

For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can’t help that patient pick up a glass...

Congress Tackles LDT Regulation: The Roles of FDA v. CMS

November 3, 2014 2:03 pm | by Richard Park, Contributing Editor | Blogs | Comments

FDA recently released its two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances...

Chinese Engineer to Plead Guilty in Medical Equipment Case

October 31, 2014 12:25 pm | by The Associated Press | News | Comments

Federal prosecutors say they have reached a plea deal with a Chinese engineer charged with stealing trade secrets from a GE Healthcare subsidiary in Waukesha. The Milwaukee Journal Sentinel reports 41-year-old Jun Xie will plead guilty to ...

Examining Medical Device Regulation and Innovation

October 23, 2014 4:25 pm | by California Healthcare Institute | News | Comments

California Healthcare Institute (CHI) today unveiled a report that provides a comprehensive overview of U.S. Food and Drug Administration (FDA) medical device review times. Working with the FDA, CHI examined a number of issues that directly...

FDA Addresses Device Recall vs. Enhancement Question

October 23, 2014 8:52 am | by AAMI | News | Comments

What’s the difference between a medical device recall and medical device enhancement? The U.S. Food and Drug Administration (FDA) has an answer. In a final guidance document released earlier this month, the FDA spells out the difference between...

Taking 'Charge' of Your Mood

October 22, 2014 9:51 am | by Sam Brusco, Editorial Intern | Blogs | Comments

As we go about our daily activities, we’re at the mercy of whatever mood we’re in. That’s all well and good when in a favorable mood, as productivity peaks, any obligation becomes more enjoyable, and whistling or singing accompanies your work...

Divergence System Offers New Approach to Anterior Cervical Fusion

October 21, 2014 12:02 pm | by Medtronic | News | Comments

Medtronic announced the U.S. launch of the DIVERGENCE Anterior Cervical Fusion System for the treatment of single-level cervical disc disease today at the 2014 Congress of Neurological Surgeons Annual Meeting in Boston. The DIVERGENCE System represents a new approach...

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