The 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.
A 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.
Invisalign, 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.
The 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 ImplantsMay 31, 2013 1:07 pm | by PR Newswire | Comments
Cochlear 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 TechnologyMay 31, 2013 1:00 pm | by Business Wire | Comments
Fujikura 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.
Two 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.
A 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.
Scientists 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.
The medical device ecosystem is changing dramatically from stand-alone “device + patient + physician” in the clinical environment to include access and mobility outside the four walls of the hospital. This inforgraphic looks at how connected health can make an impact on the cost of healthcare.
The Endurant AAA stent graft system from Medtronic, Inc. continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up.
GE Healthcare Announces Commercial Availability of New Methodology That Provides a Cancer Profile on a Single SlideMay 31, 2013 9:00 am | by Business Wire | Comments
GE Healthcare today announced at the 2013 Annual Meeting of the American Society of Clinical Oncology its plans for the commercialization of MultiOmyx ™, a ground-breaking new pathology platform, using proprietary methodology to analyze multiple proteins at a single-cell level.
NuVasive, Inc., a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce the global launch of its Maximum Access Surgery Posterior Lumbar Interbody Fusion (MAS® PLIF) procedure.
New Method to Test Breast Lesions Could Better Detect Cancer, Save Money by Reducing Repeat BiopsiesMay 31, 2013 12:05 am | by AACR | Comments
A newly developed, single-step Raman spectroscopy algorithm has the potential to simultaneously detect microcalcifications and enable diagnosis of the associated breast lesions with high precision, according to data published in Cancer Research, a journal of the American Association for Cancer Research.
Research at Lund University in Sweden gives hope that one of the most serious types of brain tumor, glioblastoma multiforme, could be fought by the patients' own immune system. The tumors are difficult to remove with surgery because the tumor cells grow into the surrounding healthy brain tissue. A patient with the disease therefore does not usually survive much longer than a year after the discovery of the tumor.