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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...

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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.

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.

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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.

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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 | Bsi | 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.

Alere MobileLink Receives FDA Clearance

August 13, 2013 12:08 pm | by PR Newswire | News | Comments

Alere Connect has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for the Alere MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.

Meeting Notice: September 11-12, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee

August 13, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On September 11, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC) devices, one of the remaining preamendments class III devices regulated under the section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) (510(k)) pathway. 

Strategy for Success to Comply with IEC 60601-1

August 12, 2013 2:19 pm | by Robert Dostert, Director of Business Development, TÜV SÜD America | Tuv Sud America | Articles | Comments

Ensuring compliance with IEC 60601-1 is simply a must for every medical device manufacturer. However, with revisions and updates, it’s difficult for a company to ensure they are constantly in compliance unless they have a dedicated expert on staff. Therefore, an excellent solution for this challenge is to partner with a company that is exactly that—an expert on the standard.

FDA Awards Contract to Develop Promising New Technology to Test Radiation Countermeasures

August 12, 2013 2:14 pm | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration has awarded a $5.6 million contract to Harvard University’s Wyss Institute for Biologically Inspired Engineering to apply its breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness.

Century Medical Submits Cardica MicroCutter XCHANGE™ 30 Cartridge for Japanese Approval

August 12, 2013 8:00 am | by PR Newswire | News | Comments

Cardica, Inc. and Century Medical, Inc. today announced that Century Medical filed for regulatory approval of Cardica's MicroCutter XCHANGE™ 30 cutting and stapling cartridge in Japan. The submission to the Pharmaceuticals and Medical Devices Agency (PMDA) includes design, validation and verification data for the MicroCutter XCHANGE 30 cartridges.

FDA approves LDR's cervical disc replacement device

August 9, 2013 1:29 pm | by Mass Device | News | Comments

Austin, Tex.-based LDR landed its 1st FDA approval for its Mobi-C device, a cervical disc replacement for patients with degenerative disc disease. The privately held company, which was founded in France but is headquartered in Texas, is marketing the product as better alternative to a last-resort procedure called anterior cervical discectomy fusion, which fuses the vertebra to ease painful symptoms of a herniated disk.

PMA Final Decisions for May 2013

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

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA.

Upcoming IDE Tracking Improvements

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

Improving patient access to new medical devices by strengthening and streamlining the clinical trial enterprise is a priority for CDRH. An important part of reaching that goal is to better track milestones in clinical trial development, Investigational Device Exemption (IDE) approval, study initiation, and study completion. 

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