Advertisement
Regulatory
Subscribe to Regulatory
View Sample

FREE Email Newsletter

FDA/American Gastroenterological Association (AGA) Co-sponsored Public Workshop: Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases, October 17-18, 2013

September 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases:  How to Estimate and Reward True Patient-Centric Value in Innovation.”

'Obamacare' Contractors Project Confidence

September 10, 2013 1:43 pm | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments

Major contractors hooking up the internal plumbing of President Barack Obama's health care law projected confidence Tuesday that they will be ready to go by an Oct. 1 deadline, even though the system is still being tested. With just three weeks to go before new state health insurance markets launch, efforts are ongoing to reliably link up government agencies, the markets themselves and private health plans.

The New FDA Draft Guidance for Biocompatibility: What You Need to Know

September 9, 2013 2:27 pm | by Thor Rollins B.S. RM(NRCM), Biocompatibility Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Blogs | Comments

In a draft guidance document, FDA has placed its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility. The draft document has been out since April and is widely available, though it has not been formally released.

Advertisement

Meeting Announcement: October 8-9, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee

September 9, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On both days the committee will discuss, make recommendations, and vote on devices indicated for use in patients with heart failure (HF).  On October 8, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the expansion of indications supported by the BLOCK HF trial...

Is Robotic Surgery as Safe as It Seems?

September 6, 2013 10:26 am | by Johns Hopkins | News | Comments

Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers. In a report published online in the Journal for Healthcare Quality...

Siemens' high-risk recall affects more than 78,000 antimicrobial tests

September 5, 2013 1:59 pm | by Mass Device | News | Comments

FDA regulators put their highest-risk Class I label on Siemens' (NYSE:SI) recall of more than 78,000 of its MicroScan Synergies plus and MicroScan rapID/S plus antimicrobial tests, warning that false test results could hinder patient care.  

ASTM Medical and Surgical Materials Committee Approves New Orthopedic Hip Implant Standard

September 5, 2013 12:09 pm | by ASTM International | News | Comments

A new ASTM International standard will provide a consistent method for analyzing hip stems used in hip replacement surgery. The new standard, ASTM F2996, Practice for Finite Element Analysis (FEA) of Nonmodular Metallic Orthopaedic Hip Femoral Stems, was developed by Subcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

July/August 2013 Digital Edition

August 27, 2013 5:07 pm | Digital Editions | Comments

Innovative control technology offers medical professionals and technicians the potential to do much more with diagnostic imaging equipment. “A New Dimension in Diagnostics,” this issue's cover story, looks at intuitive controls for radiological applications.

Advertisement

Designing Medical Electronics

August 27, 2013 3:16 pm | by Guy Francfort, Vice President, Sales and Marketing, MEGA Electronics Inc. | Mega Electronics, Inc. | Blogs | Comments

Guy Francfort, vice president of sales and marketing for MEGA Electronics Inc., was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.

Wet Platinum Personal Lubricant Receives FDA 510(k) Medical Device Approval

August 27, 2013 12:48 pm | by Business Wire | News | Comments

Wet Platinum Premium Personal Lubricant has received Section 510(k) medical device approval from the U.S. Food and Drug Administration, which allows this 100% silicone, latex-friendly product to be marketed in interstate commerce as substantially similar to other legally marketed predicate products.

HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In Destination Therapy Trial

August 27, 2013 9:10 am | by The Associated Press | News | Comments

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE...

FDA hits Fresenius with 3rd warning letter this year

August 27, 2013 8:59 am | by Mass Device | News | Comments

The FDA took issue with certain manufacturing processes at a Fresenius plant in Puerto Rico, handing the German medical healthcare company its 3rd warning letter this year. Following an April inspection, the FDA raised concerns about product labeling and complaint-handling processes at the blood bag manufacturing plant...

Hacking healthcare: Would we know if a medical device was hacked?

August 26, 2013 7:59 am | by Mass Device | News | Comments

The FDA has made medical device cybersecurity a high priority, even as it stresses that there have been no reported incidents of malicious medical device hacks or of patients harmed by a security-related issue. But that assurance is based more on assumption than fact, experts say.

Advertisement

Canada green-lights InSightec's ablation system

August 22, 2013 4:51 pm | by Mass Device | News | Comments

Canadian healthcare regulators approved InSightec's ExAblate ultrasound system, clearing the device for use against 2 different diseases. Health Canada granted ExAblate indication to break up benign uterine tumors and to alleviate painful symptoms of metastatic bone tumors.

Analysts: Device companies already absorbed excise tax

August 22, 2013 6:00 am | by Mass Device | News | Comments

Many medical device companies have long petitioned for a repeal of the 2.3% excise tax on U.S. sales, but analysts say medtech companies have already managed to absorb the tax without taking a hit to the bottom line or jacking up costs for consumers.

Hyperbaric Oxygen Therapy: Don't Be Misled

August 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.

A Closer Look: RoHS 2 Compliance Process

August 21, 2013 12:28 pm | by By Joe Langton; Senior Consultant and Program Manager; Health, Environmental, and Regulatory Services Unit, Intertek | Articles | Comments

Regulations for the Restriction of Hazardous Substances (RoHS) 2 impact the ways in which companies do business, especially in the medical device industry. On July 22, 2014, when a company places a CE mark on medical devices, they are confirming all appropriate measures were taken to ensure each product meets the RoHS 2 directive...

Covidien recalls flush syringes

August 20, 2013 1:59 pm | by Mass Device | News | Comments

Covidien recalled some lots of its Monoject syringes after discovering a sterilization mishap and labeling problem. The issues affected 14 lots in shipments that went out to customers in the U.S. and Bermuda, the Mansfield, Mass.-based medical products giant said.

Medical device recalls hit 5-quarter high

August 20, 2013 7:59 am | by Mass Device | News | Comments

Medical device makers issued more than 400 recalls during Q2, 30% more than in the previous quarter. That's higher than reported for the last 5 quarter, according to a report by Stericycle ExpertRECALL. The recalls affected about 9.2 million units, a 50% decrease in the quantity of products affected in Q1.

Financing Puts Hold on Uranium Deconversion Plant

August 19, 2013 11:00 am | by The Associated Press | News | Comments

An Idaho-based company that plans to build a facility in southeastern New Mexico to make uranium waste safe for long-term disposal has put its plans on hold because of a funding shortage.          

FDA transfers stem cell wound care review away from medical device arm

August 14, 2013 12:11 pm | by Mass Device | News | Comments

The FDA is shifting some of its wound care review responsibilities away from the Center for Devices & Radiological Health, handing them instead to the Center for Biologics Evaluation & Research. Some of the products transfered include the Apligraf diabetic foot and venous leg ulcer treatment from Organogenesis.

BSI Offers Medical Device Manufacturers Exclusive Access to Global Panel of Experts in 3 Key Cities

August 14, 2013 10:33 am | by PR Newswire | News | Comments

The Healthcare Solutions experts at BSI, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union, are offering members of the medical device community exclusive access to global industry experts at three Roadshow events in key U.S. cities in September.

Class I Medical Device Recall: Hospira Intravascular Administration Sets

August 14, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

It was discovered that there was a potential for the piercing pin on certain ISO-compliant Hospira blood sets to puncture the outer wall of the non-ISO-compliant blood bags during insertion of the pin into the blood bag. This can lead to the leakage of blood and health care provider exposure to blood products.

Rapid Changes with Portable Medical Devices

August 13, 2013 2:05 pm | by Kirk Barker, Electronic Product Manager, maxon motors | Maxon Precision Motors, Inc. | Blogs | Comments

Kirk Barker, electronic product manager at maxon motors, was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.

Cardica shoots for Japanese approval

August 13, 2013 1:23 pm | by Mass Device | News | Comments

Cardica and its distribution partner Century Medical are shooting for Japanese regulatory approval for the stapling cartridge components of Cardica's MicroCutter Xchange surgical device. Redwood City, Calif.-based Cardica sent in the cartridge design validation application to Japan's Pharmaceuticals & Medical Devices Agency today.

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading