With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.
The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death.
In the near future, a buzz in your belt or a pulse from your jacket may give you instructions on how to navigate your surroundings. Think of it as tactile Morse code: vibrations from a wearable, GPS-linked device that tell you to turn right or left, or stop, depending on the pattern of pulses you feel. Such a device could free drivers from having to look at maps, and could also serve as a tactile guide for the visually and hearing impaired.
Using the sensitive ears of a parasitic fly for inspiration, a group of researchers has created a new type of microphone that achieves better acoustical performance than what is currently available in hearing aids. The scientists will present their results at the 21st International Congress on Acoustics, held June 2-7 in Montreal.
One 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.
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 | News | 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.
New research from the University of Southampton shows that copper and copper alloys will rapidly destroy norovirus - the highly-infectious sickness bug. The virus can be contracted from contaminated food or water, person-to-person contact, and contact with contaminated surfaces, meaning surfaces made from copper could effectively shut down one avenue of infection.
Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI AdvisesMay 23, 2013 4:18 pm | by PR Newswire | News | Comments
WASHINGTON, May 23, 2013 /PRNewswire/ -- Hearing health affects a man's lifestyle, and if he wants to stay active, feel younger, and remain socially and professionally engaged, he should address any hearing loss he may be experiencing. This is the overriding message that the...
Frequent heartburn was positively associated with cancers of the throat and vocal cord among nonsmokers and nondrinkers, and the use of antacids, but not prescription medications, had a protective effect, according to data published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.
New research from the University of Southampton has shown that blind and visually impaired people have the potential to use echolocation, similar to that used by bats and dolphins, to determine the location of an object. The study, which is published in the journal Hearing Research, examined how hearing, and particularly the hearing of echoes, could help blind people with spatial awareness and navigation.
A new study looking at sleep-disordered breathing and markers for Alzheimer's disease risk in cerebrospinal fluid and neuroimaging adds to the growing body of research linking the two. But this latest study also poses an interesting question: Could AD in its "preclinical stages" also lead to SDB and explain the increased prevalence of SDB in the elderly?
The University of Sydney and ResMed partner to accelerate research in sleep-disordered breathing and biomedical engineeringMay 13, 2013 4:30 pm | by PR Newswire | News | Comments
SYDNEY, May 13, 2013 /PRNewswire/ -- The University of Sydney and ResMed Limited today announced a new partnership that includes significant and long-term funding of research at the University, ultimately benefitting the hundreds of millions of sufferers of sleep-disordered breathing worldwide.
Scientists at Princeton University used off-the-shelf printing tools to create a functional ear that can "hear" radio frequencies far beyond the range of normal human capability. The researchers' primary purpose was to explore an efficient and versatile means to merge electronics with tissue.
WASHINGTON, May 1, 2013 /PRNewswire/ -- In recognition of Better Hearing and Speech Month, the Better Hearing Institute (BHI) is encouraging people with questions about their hearing to take advantage of the warm days of spring and go out and "window shop" by visiting a...
The manufacture of hearing aids has traditionally involved a time-consuming, manual process that limited the amount of production that could be achieved by a single technician. However, with the implementation of rapid prototyping technology alongside CAD/CAM solutions, this process has been sped up exponentially. This article looks at the changing trend for the production of hearing aids.
LAGUNA BEACH, Calif.--(BUSINESS WIRE)--Apr 23, 2013--Healthcare advertising is seeing more medical device companies going direct to consumers thanks to the effectiveness of the Internet in reaching people looking for answers online to their medical conditions. This has made it important for...
A central Kentucky family won a $7.24 million verdict after a jury concluded that a company that makes implantable hearing aids knowingly sold a defective device that shocked a 6-year-old girl. The jury in federal court in Louisville awarded $6.25 million in punitive damages and $994,000 in...
Sophono, Inc., manufacturer of abutment-free, implantable, bone conduction hearing devices, has received clearance from the FDA for magnetic resonance imaging. With the clearance, individuals in the United States who have the Sophono Alpha 2 System can undergo MRI in both 1.5 and 3-tesla magnetic fields without removing the magnetic implant.
NASHVILLE, Tenn., April 11, 2013 /PRNewswire/ -- Sleep Nation, Inc., a national provider of CPAP supplies, today announced a major accomplishment as it has signed contracts with the Centers for Medicare & Medicaid Services (CMS) to be reimbursed for all competitive bid...
First Clinical Study Demonstrates Vent-Os Sinus Dilation System Effectively Establishes and Maintains Patency of Maxillary Sinus OstiaApril 11, 2013 9:00 am | by The Associated Press | News | Comments
PALO ALTO, Calif.--(BUSINESS WIRE)--Apr 11, 2013--SinuSys Corporation, an innovative sinus health company, today announced that the Vent-Os™ Sinus Dilation System met its primary safety and effectiveness endpoints in its initial clinical study. The Vent-Os System is designed to gently open the...
Henkel Corporation will host the first Loctite Medical Device Adhesive Seminar of 2013 on Tuesday, May 21, in Minneapolis, Minn. This comprehensive program will provide design, product and manufacturing engineers with an overall knowledge of adhesive technologies used in the design and assembly of medical devices.
Around 17 million people in Germany suffer from impaired hearing. For many of them, their hearing is so damaged that a standard hearing aid is no longer enough. A new device will improve patients’ hearing and can be implanted during outpatient surgery.
As demonstrated in these videos, sitting at rest, the adaptive and multifunctional material is smooth, clear and flat; droplets of water or oil on its omniphobic surface flow freely down its surface. Stretching or bending it makes the fluid surface rougher. The rough surface is opaque, and also confers the ability to precisely control the movement of water or oil droplets.
Imagine a tent that blocks light on a dry and sunny day, and becomes transparent and water-repellent on a dim, rainy day. Or highly precise, self-adjusting contact lenses that also clean themselves. Or pipelines that can optimize the rate of flow depending on the volume of fluid coming through them and the environmental conditions outside.
VALENCIA, Calif.--(BUSINESS WIRE)--Mar 20, 2013--Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that it received FDA, Health Canada and TÜV approval for the global distribution of HiRes Optima™* sound processing. The world’s...