By Sherrie Conroy
FDA has awarded $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated. In August 2011, the agency released the strategic plan for: “Advancing Regulatory Science at FDA.”
More recently, the agency announced a related innovation initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.” “These partnerships represent a critical, necessary and creative investment – one that will benefit not just FDA and academia, but also American consumers and industry,” said FDA Chief Scientist Jesse L. Goodman. “The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions.”
Read Full Story
Articles
Edwards Lifesciences Corp has received approval from FDA for the transfemoral delivery of the Edwards SAPIEN transcatheter aortic heart valve for the treatment of inoperable patients with severe symptomatic aortic stenosis.
According to the company, this is the first US commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN valve enables multidisciplinary heart teams to replace a patient's diseased aortic valve without traditional open-heart surgery and while the heart continues to beat—avoiding the need for cardiopulmonary bypass.
Read Full Story
Advertisement
 Tiny Seals – Huge Quality
Seal it right. Right from Apple. Apple Rubber Products offers medical silicone seals in a wide range of shapes and sizes – from inside diameters (I.D.) .015 inches (0.4 mm) to .079 inches (2.0 mm) - to meet the rigorous demands of today's medical industry. Biomedical testing and full lot traceability available, along with our Class 10,000, ISO Class 7 Cleanroom, give you the quality you demand for any medical application – directly from our USA plant. www.applerubber.com
|
Senators Richard Burr (R-NC), Amy Klobuchar (D-MN), and Michael Bennet (D-CO) have introduced legislation that would help boost medical innovation by reducing regulatory burdens that unnecessarily delay beneficial new medical products from reaching patients. The Medical Device Regulatory Improvement Act would help streamline FDA’s regulation of medical devices to continue to spur innovation and help get new, lifesaving products to the market quicker without compromising consumer safety.
Boston Scientific issued a statement commending the senators for “their thoughtful leadership in introducing this new legislation designed to streamline the Food and Drug Administration's regulation of medical devices.” The device maker says that the bill is “an important step in transforming the process of bringing life-enhancing and lifesaving medical technologies to market in a safe and more efficient and predictable manner.”
Over the past few years, FDA’s regulation has become increasingly longer and more difficult, delaying, and in some cases preventing, new and innovative devices from reaching the market. Recent studies show that the average time to approve a 510(k) application has increased 43% from the 2003–2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%.
Read Full Story
Advertisement
 Choosing an RTOS for Remote-care Medical Devices
Three trends are driving a dramatic increase in the number and diversity of remote-care medical devices entering the market: aging populations in industrialized countries, pressures to reduce health care costs, and a new focus on primary and secondary care. Download this free whitepaper on choosing an embedded OS for remote-care medical devices. It provides a high-level list of requirements that device manufacturers can use to evaluate OSs they are considering. www.qnx.com
|
MET Labs is launching a program for testing medical devices for susceptibility to radio-frequency identification (RFID) emissions. The program, which is set to debut Dec 6, is to determine potential adverse RFID emissions on electronic medical devices. After months of development with AIM Healthcare Initiative (HCI) and FDA, the program’s test protocol can now undergo validation using actual medical devices.
Medical device manufacturers are invited to participate by submitting representative devices to MET Labs for testing, which will take approximately one day to complete for each submitted device. Eligible medical devices are those covered by the IEC 60601 family of standards.
Submitted equipment will be tested in several different RFID frequency bands, and participants will receive a confidential test report. If equipment is found to be susceptible to RF interference, MET Labs will assist manufacturers with strategies for minimizing or eliminating interference effects.
Read Full Story
New Products
A four-quadrant PWM servo controller from Maxon is designed for use with DC motors up to 72W. The Escon 36/2 DC is a fast digital current controller with bandwidth for optimal motor current and torque control. The drift-free dynamic speed behavior enables a speed range of 1–150,000rpm. The servo controller provides a wide range of functions, with fully configurable digital and analog inputs and outputs. Use with the company’s range of motors enables high demanding and dynamic drive options. It can be run in various operating modes (speed controller [closed loop], speed controller [open loop], and current controller).
The ultracompact servo controller is controlled by means of an analog set value. The value can be specified by means of analog voltage, an external or internal potentiometer, a defined value, or by means of a PWM signal with variable duty cycle.
Read Full Story
Advertisement
 New white paper on Hydrophilic Coatings Product Development Considerations
Biocoat, Inc has made available a new informative 8-page technical white paper on product development issues when considering use of hydrophilic coatings. The white paper covers the general properties of hydrophilic coatings and the most commonly used types of medical devices requiring high lubricity.
This paper provides design engineers with in-depth guidance on understanding the applications, how to evaluate vendors and the cost implications of different coating processes. Click here for a free copy.
|
Microchip Technology Inc, which develops microcontroller, analog, and Flash-IP solutions, has signed Milford, CT-based Diversified Engineering as a new Medical Design Partner Specialist. Diversified Engineering joins Microchip’s program of Design Partner Specialists in areas such as medical electronics, wireless design, touch sensing, motor control, and smart energy. Diversified was selected for the program because of its extensive knowledge of Microchip’s product portfolio and its proven track record of taking concepts to production within the unique requirements of the embedded medical-products market.
Read Full Story
American Portwell Technology has launched the PCOM-B217VG-VI-ECC embedded computer module to add Intel's second-generation quad-core and dual-core Intel Core i7/i5 processors to its Type 6 COM Express(tm) product portfolio. The Type 6 connector pin assignment is the successor to Type 2, adding the DisplayPort and high-speed USB 3.0 peripheral support contained in the latest high performance processors and chip sets in place of parallel PCI and IDE interfaces that are no longer present in most new chip sets.
This announcement means that medical OEMs using Portwell COM Express modules can either continue to follow Portwell's Type 2 product roadmap or migrate to Type 6. Both pinout types are provided by Portwell for the second-generation Core i7/i5 with 7-year life cycles (through 2018).
The PCOM-B217VG-VI-ECC module features an error-correcting ECC memory controller for higher system and data reliability, and Turbo Boost Technology 2.0, which dynamically increases the operating frequency of processor cores beyond baseline levels (even beyond 3GHz) according to workload and real-time power and temperature measurements.
Read Full Story
News from Medical Design
Sponsored Featured Links
Boker's 2011 Washer Catalog
Boker's 2011 Washer Catalog features over 25,000 non-standard flat washer sizes, available with no tooling charges, outside diameters of 0.080" to 5.140" and over 2,000 material options for endless possibilities.
www.bokers.com/mee
2012 PROTO LABS CALENDAR
Designed by designers and engineered for engineers, our annual Cool Parts Calendar features the visions of product developers across the nation and around the world. It features monthly contests, industry tradeshow dates, and (of course) those elusive days of the week. Request your calendar today
Medical Molding
Precision plastic components for Medical OEM projects require more than tight tolerances and consistent quality. They often require manufacturing in a clean environment and a solid understanding of the application or related standards. Learn More
Document translation: How to maximize accuracy and lower costs
International Language Services meets your standards for accuracy and expertise. Download our new white paper: “How to leverage translations to save time and cost.”
|
