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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...

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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...

Why Might the Medical Device Industry Lose $34 Billion?

October 20, 2014 11:05 am | by A.T. Kearney | News | Comments

The medical device industry has enjoyed stability, strong growth, healthy margins and above average price-to-earnings ratios over the last 20 years. However, disruptive change is already underway and the future of the industry will be different...

Congress Tackles LDT Regulation: Labs Acting Like IVD Manufacturers

October 17, 2014 4:38 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, FDA 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...

Students Sharpen Research Skills with the FDA

October 17, 2014 3:49 pm | by Nysia George, Ph.D., Intern Program Coordinator, and Tom Powers, Communication Officer; National Center for Toxicological Research | Blogs | Comments

Biology. Chemistry. Bioinformatics. Toxicology. Practical, hands-on laboratory work is important for all college students who want to become scientists — but, for many of them, such experiences are out of reach. That’s one of the reasons why every...

CE Mark for Boston Scientific’s Full-Body MRI Safe Pacemaker

October 17, 2014 9:14 am | by PR Newswire | News | Comments

Boston Scientific Corporation has received CE Mark approval for the ACCOLADE pacemaker family. When implanted with the company's INGEVITY leads, ACCOLADE pacemakers are the first to enable patients to receive full-body MRI scans in both 1.5...

Congress Needs to Give Green Light to Health IT Innovation

October 16, 2014 10:02 am | by David LeDuc, Sr. Director of Public Policy, Software & Information Industry Association | Blogs | Comments

Healthcare systems around the world are being challenged by aging populations, chronic illness and revolutionary—but expensive—treatments. Appropriate solutions are often not available to patients in need, while medical providers, academics...

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