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For Medical Device Industry, Fewer Recalls but Further Complexity

October 14, 2014 8:30 am | by Mike Rozembajgier, Stericycle | Blogs | Comments

Product recalls happen daily across industries and geographies. While each recall event presents its own challenges, when a medical device is recalled the process involved in alerting consumers and retrieving product is quite complex. Recalls...

Gaming Through Clinical Trials

October 13, 2014 2:41 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Recently, I saw a news piece out of Carnegie Mellon University where researchers supported the use of “video game” style trials of life science hypotheses to prevent the instance of error and fraud. Massive online laboratories would be established...

3D-Printed Cardiovascular Model Listed as a Class 1 Medical Device

October 13, 2014 12:14 pm | by Materialise NV | News | Comments

Materialise NV has listed its 3D-printed cardiovascular HeartPrint models as a medical device in the USA and EU markets. After years of 3D printing anatomical models for educational and research purposes, the Company addressed the need for models that can assist with...

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First Drug-Coated Angioplasty Balloon Catheter Approved by FDA

October 13, 2014 9:06 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter. This is the first drug-coated balloon used to re-open arteries in the thigh and knee when narrowed or blocked as a result of peripheral artery disease...

5 Key Lessons to Successfully Prepare and Publish Data to the FDA’s GUDID

October 13, 2014 8:30 am | by Denise Odenkirk, Senior Director, Industry Solutions, GHX | Blogs | Comments

While the deadline for medical device companies to submit Class III product data to the FDA's Production Global UDI Database (GUDID) passed on September 24, 2014, the remaining 90 percent of all medical device implantables, as well as products...

IEEE Technology Time Machine Takes on the Future of Health

October 9, 2014 4:06 pm | by Bruce Wheeler, IEEE | Blogs | Comments

Innovation is driving a seemingly exponential growth of health-monitoring devices, many aimed at consumers with accuracy and reliability that falls far short of what is needed in the highly regulated healthcare market. Innovators need to be...

FDA’s Program Alignment Addresses New Regulatory Challenges

October 9, 2014 11:04 am | by Margaret A. Hamburg, Commissioner, U.S. Food and Drug Administration | Blogs | Comments

Over the last year, a group of senior FDA leaders, under my direction, were tasked to develop plans to modify FDA’s functions and processes in order to address new regulatory challenges. Among these challenges are: the increasing breadth and...

FDA Clearance: Are Your Mobile Applications Being Used for Diagnosis Without It?

October 9, 2014 8:30 am | by Pierre Lemire, President and CTO, Calgary Scientific | Blogs | Comments

On August 1st, the FDA released new rules that exempts many medical applications created for mobile devices from its regulatory scope. In general, the new rules are targeted at consumer applications and devices that the guidelines say are...

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Unique Device Identifier Compliance Solution

October 8, 2014 8:30 am | by MDT Staff | QAD | Product Releases | Comments

QAD Inc. announced today it has developed a solution for medical device manufacturers to help meet the Unique Device Identifier (UDI) rules as required by the Food and Drug Administration (FDA). The FDA issued a rule to establish a system...

New MedTech Innovations to Face Significant Reimbursement Challenges

October 7, 2014 9:31 am | by AdvaMed | News | Comments

A new study by the Analysis Group shows that private insurers are rapidly adopting new provider payment models – including pay-for-performance and financial risk-sharing arrangements – and tightening coverage evidence requirements for new...

Ramifications of UDI Requirements

October 7, 2014 8:30 am | by Craig Jones, VP Global Supports Services, PRISYM ID | Blogs | Comments

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But there are regulatory maneuvers afoot too. The phased introduction of Unique Device Identification (UDI) requirements...

FDA Invents: How Technology Transfer Gets FDA Inventions from Lab to Marketplace

October 6, 2014 2:18 pm | by Alice Welch, Ph.D, Director — Technology Transfer Program, FDA | Blogs | Comments

If you think the term “government invention” is an oxymoron — well, think again. You may be surprised to learn that many of the breakthrough technologies that shape our lives today are the brainchildren of government researchers — including those...

Congress Tackles LDT Regulation: User Fees and FDA Resources

October 6, 2014 8:50 am | by Richard Park, Contributing Editor | Blogs | Comments

Last week, FDA finally 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...

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Increase Efficiency by Combining Bioburden and Tests of Sterility

October 6, 2014 8:30 am | by Sean Shepherd, Sr. Study Director, Nelson Laboratories | Blogs | Comments

When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device...

Zero-Gravity Suspended Radiation Protection System

October 2, 2014 2:34 pm | by PresseBox | News | Comments

CFI Medical, a leading manufacturer of innovative radiation protection products, announced CE (Conformité Européenne) approval for the Zero-Gravity Suspended Radiation Protection System Floor Unit today, paving the way for its widespread use...

New Data Dashboard Tool Shares FDA’s Inspection, Compliance, and Recall Data

October 2, 2014 2:02 pm | by Douglas Stearn, Director of the Office of Enforcement and Import Operations, FDA | Blogs | Comments

As part of our commitment to transparency FDA is pleased to announce that we have released a new online tool to provide insight into our compliance, inspection, and recall activities. This new dynamic tool represents a departure from the...

The FDA Takes Steps to Strengthen Cybersecurity of Medical Devices

October 1, 2014 10:29 am | by FDA | News | Comments

To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The final guidance, titled...

CE Mark for LoneStar Heart’s Hydrogel Implant for the Treatment of Advanced Heart Failure

October 1, 2014 10:25 am | by PR Newswire | News | Comments

LoneStar Heart, Inc. has announced that it received the CE Mark for its Algisyl-LVR hydrogel implant, the company's lead product for the treatment of advanced heart failure (HF). Classified in Europe and in the U.S. as a medical device, Algisyl-LVR...

FDA’s New Roadmap for Progress: Strategic Priorities 2014-2018

October 1, 2014 10:18 am | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

The U.S. Food and Drug Administration regulates products that represent about 20 cents of every dollar American consumers spend on products. This includes the safety and effectiveness of drugs, medical devices, and vaccines, the safety of blood...

FDA Awards Grants to Stimulate Device Development for Rare Diseases

October 1, 2014 9:33 am | by FDA | News | Comments

The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter...

Mobile Devices in Medicine: Opportunity or IT Dilemma?

October 1, 2014 8:30 am | by Charles Settles, Product Analyst, TechnologyAdvice | Articles | Comments

Integration, network architecture, and maintenance of electronic medical devices has long been the purview of medical information technologists (ITs). However, the rise of consumer mobile devices presents a new and growing problem — or opportunity...

Homeland Security and FDA Address Medical Device Cybersecurity

September 30, 2014 11:53 am | by AAMI | News | Comments

The Department of Homeland Security is joining forces with the U.S. Food and Drug Administration (FDA) to tackle the issue of medical device cybersecurity—a tacit recognition of the emerging vulnerabilities associated with healthcare technology...

Alimera, pSivida Say FDA Clears Eye Implant

September 29, 2014 10:32 am | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, a condition that can cause blurred vision and blindness.

CE Mark for CVRx's Barostim neo System for the Treatment of Heart Failure

September 29, 2014 10:28 am | by PR Newswire | News | Comments

CVRx, Inc., a private medical device company, announced today it received CE Mark approval from the National Standards Authority of Ireland (NSAI) of the Barostim neo System for the treatment of heart failure.  The therapy is approved for use...

FDA Finalized Guidance 510(k) and New Draft Guidance

September 29, 2014 8:30 am | by Jonathan S. Kahan, partner, John J. Smith, partner, Jennifer A. Henderson, counsel, Danielle C. Woodlee, associate; Hogan Lovells | Articles | Comments

On July 28, 2014, the U.S. Food and Drug Administration (FDA) finalized its guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Final Guidance), the draft version of which was released...

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