The Essential Resource for the Medical Design Engineering Community
Evaluation of Automatic Class III Designation (De Novo) Decision: K121291 added
June 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | CommentsThe Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. The De Novo process applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices.
Consumer Updates - WANTED: Consumers to Report Problems
June 3, 2013 12:00 am | by U.S. Food & Drug Administration | News | CommentsA new consumer-friendly form is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products.
3-D Printing Goes from Sci-Fi Fantasy to Reality
June 2, 2013 9:37 am | by MARTHA MENDOZA, AP National Writer, Associated Press | News | CommentsInvisalign, a San Jose company, uses 3-D printing to make each mouthful of customized, transparent braces. Mackenzies Chocolates, a confectioner in Santa Cruz, uses a 3-D printer to pump out chocolate molds. And earlier this year, Cornell University researchers used a 3-D printer, along with injections of a special collagen gel, to create a human-shaped ear.
Custom-Designed Photo-Etched Lead Frames
May 31, 2013 5:21 pm | by MDT Staff | Photofabrication Eng. Inc. | Product Releases | CommentsPhotofabrication Engineering (PEI) has expanded its manufacturing capabilities for custom-designed, photochemically-etched surface-mount and insert-mount lead frames for integrated circuit manufacturing. These lead frames are used in a wide variety of applications...
World’s Highest dB Output in a Small Package
May 31, 2013 5:13 pm | by MDT Staff | Product Releases | CommentsTransducers USA has announced the release of their new sounder, producing the world’s highest dB output in a package of matchbook size. The sound level of Transducers USA’s new model TRPS-07 is ideal for a product whose sound output level will override any other possible sounds that may be within its area.
Torque Inserts Deliver Ideal Pivoting Capabilities
May 31, 2013 5:02 pm | by MDT Staff | Reell Precision Manufacturing Corp. | Product Releases | CommentsReell torque inserts have introduced a new category of torque control hinges delivering exceptional pivoting capabilities without the standard appearance of conventional hinges. Depending on model, the torque inserts uniquely press-fit into a variety of materials via a keyed cavity or can be plastic over-molded.
Spinning Clinch Bolts Enable Captivated Screw to Spin
May 31, 2013 4:54 pm | by MDT Staff | Product Releases | CommentsPEM spinning clinch bolts for use in thin metal sheets introduce one-piece captive screw solutions whose controlled clinching action during installation permanently captivates the screw while allowing it to spin freely in the sheet.
Distributing Healthcare
May 31, 2013 3:20 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | CommentsOne of the most interesting things about my position is seeing the changes in one of the most dynamic industries around—the medical device industry (and, in a broader sense, the healthcare industry). In my 13+ years of reporting on this industry, I’ve seen many changes and technological advances. It truly is remarkable to think about how far certain sectors of the industry have come in what is really a very short period of time.
The Science of Ceramics in Hip Joint Replacements
May 31, 2013 2:56 pm | by Yannick Galais, Commercial Manager, Morgan Advanced Materials | Morgan Advanced Ceramics | Articles | CommentsCeramic materials have been used for artificial joints since the 1970s, yet the need for smaller medical implants with more complicated structures has created exciting new opportunities for those manufacturing ceramic solutions for the medical market. As a result, detailed and complex ceramic components are becoming increasingly specified for a wide range of applications.
FDA Clears Medical Device Developed by OHSU and AMES Technology for Muscle and Joint Rehabilitation
May 31, 2013 2:11 pm | by Oregon Health & Science University | News | CommentsThe Food and Drug Administration today granted 510(k) clearance to a muscle and joint rehabilitation medical device developed by OHSU Scientist Dr. Paul Cordo, Ph.D., and AMES Technology, Inc. AMES is an Oregon Health & Science University spinoff company established to transform Dr. Cordo's OHSU research findings into a rehabilitation medical device for use in hospitals and clinics.
Cochlear Americas Receives FDA Approval for the First and Only Ear Level Accessory for Waterproof Hearing with Cochlear Implants
May 31, 2013 1:07 pm | by PR Newswire | News | CommentsCochlear Americas, the global leader in implantable hearing solutions, announced today that the US Food & Drug Administration (FDA) has approved a one-of-a-kind Aqua Accessory compatible with the Cochlear Nucleus 5 Sound Processor. The Aqua Accessory is a custom cover with a double zip lock seal designed to hold the processor and coil inside, and can be worn behind the ear in the normal position.
Fujikura Ltd and Micro-Imaging Solutions Enter into License Agreement for CMOS-based Imaging Technology
May 31, 2013 1:00 pm | by Business Wire | News | CommentsFujikura Ltd and Micro-Imaging Solutions (MIS) announced that they have entered into a license agreement to jointly co-market nano-sized, complementary metal-oxide semiconductor, or CMOS, based endoscopes. The collaboration leverages the large, commercial scale production capabilities of Fujikura and the proprietary imaging technology of MIS.
New Single Virus Detection Techniques for Faster Disease Diagnosis
May 31, 2013 12:11 pm | by The Optical Society | News | CommentsTwo independent teams have developed new optics-based methods for determining the exact viral load of a sample by counting individual virus particles. These new methods are faster and cheaper than standard tests and they offer the potential to conduct the measurements in a medical office or hospital instead of a laboratory.
New Technique Alleviates Painful Bone Metastases
May 31, 2013 12:06 pm | by Fox Chase Cancer Center | News | CommentsA high-dose of ultrasound targeted to painful bone metastases appears to quickly bring patients relief, and with largely tolerable side effects, according to new research presented by Fox Chase Cancer Center scientists at the 49th Annual Meeting of the American Society of Clinical Oncology on Monday, June 3.
Lead Acts to Trigger Schizophrenia
May 31, 2013 12:04 pm | by Columbia University's Mailman School of Public Health | News | CommentsScientists at Columbia University's Mailman School of Public Health and the Johns Hopkins University School of Medicine say their findings suggest a synergistic effect between lead exposure and a genetic risk factor, and open an avenue to better understanding the complex gene-environment interactions that put people at risk for schizophrenia and other mental disorders.
