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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...

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...

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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...

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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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FDA Clears Glucose Monitoring System for Use in Hospital Critical Care Units

September 25, 2014 11:26 am | by U.S. Food and Drug Administration | News | Comments

Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring...

First-Ever Conception Assistance Device FDA-Cleared for Home Use Launches U.S. Over-the-Counter Sales

September 25, 2014 9:56 am | by Rinovum Women’s Health | News | Comments

Rinovum Women’s Health announced today that The Stork OTC—the only home-use conception assistance device on the market cleared by the FDA for over-the-counter sales—is available without a prescription in stores and online at the company's...

HealthPatch MD Biosensor Receives FDA Clearance for Monitoring Patients at Home

September 25, 2014 9:23 am | by Vital Connect | News | Comments

Vital Connect announced today that it received FDA clearance for use of its HealthPatch MD biosensor for monitoring patients in their homes. As an industry pioneer of wearable biosensor technology, Vital Connect now enables medical professionals...

2014 Half-Year Review

September 24, 2014 11:33 am | by EP Vantage and Eileen Whitmore, Art Director | News | Comments

The editorial team at EP Vantage has released its 2014 Half-Year Review of the medtech sector. Highlighted in this infographic are several of the interesting findings that are featured in the report. Positives include faster FDA review times, venture...

Prevantics Device Swab Receives FDA 510k Market Authorization

September 24, 2014 11:04 am | by PDI | News | Comments

PDI, manufacturer of market-leading infection prevention products and solutions, announced the introduction of Prevantics Device Swab, the only Chlorhexidine Gluconate/alcohol solution that has received market authorization from the U.S. Food...

Boston Scientific Enrolls First Patients In U.S. Trial Of The Lotus Valve System

September 24, 2014 10:42 am | by PR Newswire | News | Comments

Boston Scientific Corporation has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis and who are considered to be at either high...

Fast and Accurate PCR-Based Diagnostics of Gastroenteritis

September 23, 2014 11:02 am | by B3C Newswire | News | Comments

Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the European launch of Amplidiag Bacterial GE, marketed as a CE-IVD product under...

First Test to Identify Five Yeast Pathogens Directly from a Blood Sample

September 23, 2014 9:30 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis...

CE Mark Grants St. Jude’s Pacing Lead Expanded Patient Access to MRI Scans

September 22, 2014 9:31 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, has announced CE Mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads, allowing existing and future patients with the devices access to magnetic resonance...

FDA Approves Gore's VIABAHN Endoprosthesis for Endovascular Treatment of In-Stent Restenosis

September 22, 2014 9:22 am | by The Associated Press | News | Comments

W. L. Gore & Associates, Inc. (Gore) today announced that the Food and Drug Administration (FDA) has approved the GORE VIABAHN Endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA). Now...

Congress Tackles LDT Regulation: IVD Innovation and the Device Tax

September 19, 2014 2:20 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, the House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing on FDA’s notification to Congress at the end of July that it intends to issue draft guidance on a framework for oversight...

Industry Associations Support Continued Efforts to Repeal Device Tax

September 19, 2014 1:49 pm | by MITA, AdvaMed, and MDMA | News | Comments

The Medical Imaging & Technology Alliance (MITA), Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today announced their collective support for the continued bipartisan efforts to...

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