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Sophono Alpha 2 Hearing System Receives FDA Clearance for Use with MRI

April 11, 2013 2:14 pm | by PRNewswire | News | Comments

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.

Sleep Nation, Inc. Wins All 100 Medicare Competitive Bid Areas

April 11, 2013 2:00 pm | by PR Newswire | News | Comments

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 Ostia

April 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...

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Henkel Hosts Loctite Medical Device Adhesive Seminar

April 10, 2013 3:54 pm | by Henkel Corporation | News | Comments

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.

Regaining Proper Hearing at Last

April 9, 2013 10:38 am | by Fraunhofer | News | Comments

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.

Demonstration: Adaptive Material Inspired by Tears

April 8, 2013 3:33 pm | by Kristen Kusek, Wyss Institute for Biologically Inspired Engineering at Harvard | Videos | Comments

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.

Researchers Design New Adaptive Material Inspired by Tears

April 8, 2013 11:42 am | by Kristen Kusek, Wyss Institute for Biologically Inspired Engineering at Harvard | News | Comments

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.

HiRes Optima™ Sound Processing from Advanced Bionics Receives Worldwide Approval

March 20, 2013 5:00 pm | by The Associated Press | News | Comments

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...

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Cook Medical Launches Salivary Duct Access Products as Minimally Invasive Alternative to Open Surgery

March 18, 2013 9:03 am | by The Associated Press | News | Comments

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Mar 18, 2013--Cook Medical has launched a suite of salivary duct access products that offer minimally invasive options for the treatment of obstructive salivary gland disease. Minimally invasive treatment of obstructive salivary gland disease can reduce the need...

SinuSys Corp. Expands Executive Team

March 18, 2013 9:00 am | by The Associated Press | News | Comments

PALO ALTO, Calif.--(BUSINESS WIRE)--Mar 18, 2013--SinuSys Corporation, an innovative sinus health company, today announced recent additions to its management team as it expands its global commercialization activities for the SinuSys Dilation System and continues its progress toward FDA 510(k)...

Lantos Technologies Receives FDA Clearance for its 3D Ear Scanning System

March 18, 2013 8:55 am | by The Associated Press | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar 18, 2013--Lantos Technologies, Inc. today announced that it has received clearance from the United States Food & Drug Administration (FDA) to market the Lantos 3D Ear Scanning System. Initially developed in the laboratories of Massachusetts Institute of...

Satiety Inc. Escapes Stomach Stapling Lawsuit

March 13, 2013 5:02 pm | by Mass Device | News | Comments

Satiety Inc. can put a 4-year personal injury lawsuit in its rearview mirror now that the case has been dismissed by a federal judge. The plaintiff, Lucia Burgos, failed to prove that the Palo Alto, Calif.-based medical device company's stomach stapling device violated the protocols of its investigational device exemption from the FDA.

Innovative HiFocus Mid-Scala Electrode from Advanced Bionics Receives Approval in Canada

March 4, 2013 5:00 pm | by The Associated Press | News | Comments

VALENCIA, Calif.--(BUSINESS WIRE)--Mar 4, 2013--Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that it received Health Canada approval for the HiFocus™ Mid-Scala* electrode. Last month, AB received TÜV approval for...

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Swallow Solutions, LLC, Secures $1.046 Million Series A Financing

March 1, 2013 9:26 am | by The Associated Press | News | Comments

MADISON, Wis.--(BUSINESS WIRE)--Mar 1, 2013--Swallow Solutions, LLC (Swallow Solutions), a life sciences company with a novel dysphagia treatment platform, announced today it has raised $1.046 million in Series A financing, led by Venture Management, LLC, with participation from NEW Capital Fund,...

Sonitus Medical Announces Affirmative Update Regarding Bone Conduction Oral Appliances in American Academy of Otolaryngology-Head and Neck Surgery Policy Statement on Implantable Hearing Devices

February 27, 2013 10:01 am | by The Associated Press | News | Comments

Sonitus Medical, Inc., a medical device company that manufactures the world's first and only non-surgical and removable hearing device to transmit sound via the teeth, announced today that the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) approved a policy statement on...

Medtronic Adds to Intersect ENT's $30M Series D Round

February 25, 2013 12:52 pm | by Mass Device | News | Comments

Medtronic is once again backing sinus implant developer Intersect ENT, this time in a $30 million Series D round led by new investor Norwest Venture Partners. All of Intersect's existing "significant" backers participated in the latest round, including Kleiner Perkins Caufield & Byers, U.S. Venture Partners, PTV Sciences and Medtronic, according to a press release.

Biolase Expands Soft-Tissue Laser to New Markets

February 8, 2013 9:59 pm | by Mass Device | News | Comments

Biolase wins a nod from the FDA to expand its soft-tissue laser to 19 different markets. Biolase (NSDQ:BIOL) won FDA approval for the use of its 940nm Diolase 10 laser in a range of different markets. The federal watchdog agency also cleared 80 new procedures for the device. The Irvine, Ca-based dental laser company said it can now sell into more than 20 new markets, including ear, nose and throat...

HiFocus Mid-Scala Electrode from Advanced Bionics Receives Approval in Europe

February 4, 2013 7:53 pm | by The Associated Press | News | Comments

VALENCIA, Calif.--(BUSINESS WIRE)--Feb 4, 2013--Advanced Bionics (AB), a global leader in cochlear implant technology and a company of the Sonova Group, announced today that it received TÜV approval in Europe for the HiFocus™ Mid-Scala* electrode. The latest offering in AB’s HiFocus™ electrode...

Continuous Positive Airway Pressure Machine: Components, Characteristics, and Device Implementation

January 23, 2013 11:20 am | by Luis Puebla | Freescale Semiconductor, Inc. | Articles | Comments

According to the National Sleep Foundation, more than 18 million American adults have obstructive sleep apnea (OSA). OSA occurs when the back muscles of the throat relax while sleeping, causing the airway to narrow, resulting in snoring. These muscles could also completely block the flow of air to the lungs. When the brain detects a lack of oxygenation, it sends an impulse to the muscles forcing them to restart the breathing process.

Surgical Innovations partners Universities to optimise design and manufacture of medical devices

December 10, 2012 11:21 am | by Surgical Innovations | News | Comments

Surgical Innovations (SI) – designer and manufacturer of creative solutions for minimally invasive (‘keyhole’) surgery – has successfully completed two Knowledge Transfer Partnership (KTP) collaborations with both the University of Leeds and the University of Bradford, to optimise their range of laparoscopic surgery devices.

ENTrigue Surgical Introduces Ventera-R Sinus Dilation System for the U.S.

September 20, 2012 9:02 am | by PRNewswire | News | Comments

ENTrigue Surgical, Inc., a privately held company that develops, manufactures and distributes medical devices used for Ear, Nose and Throat surgical procedures, announced today the limited commercial release in the United States of its Ventera®-R Sinus Dilation System for revision surgery of the frontal, maxillary and sphenoid sinuses.

‘Invisible’ Hearing Aids are the Future

September 11, 2012 9:41 am | by GBI Research | News | Comments

Hearing aids are set to make big noise in the medical devices market, as innovative new technologies shrink hearing aids to turn up their cosmetic appeal, states a new report by medical devices experts GBI Research. The new report* states that growing elderly populations, government healthcare initiatives in emerging countries...

Cook Medical Launches Otolaryngology/Head and Neck Surgery Division

September 10, 2012 2:56 pm | by BUSINESS WIRE | News | Comments

Cook Medical, a world leader in minimally invasive medical device technology, has launched its new Otolaryngology/Head and Neck Surgery (OHNS) clinical division to bring the benefits of the company’s devices for non-surgical procedures to a new group of physicians and the patients they treat. Recognizing the need for specialized minimally invasive devices in otolaryngology...

ENTrigue Surgical Announces Sinus Surgery Collaboration with fiagon GmbH

September 6, 2012 2:03 pm | by PRNewswire | News | Comments

ENTrigue Surgical, Inc., a San Antonio, Texas-based company that designs, develops, manufactures and distributes medical devices used for Ear, Nose and Throat surgical procedures, announced today a collaboration agreement with fiagon GmbH, a company based in Berlin, Germany, that develops and manufactures a new generation of intelligent and highly portable navigation systems for ENT...

Cochlear Americas Receives FDA Approval of the World's Thinnest, Full Length Electrode for Cochlear Implantation

June 12, 2012 10:19 am | News | Comments

Cochlear Americas announced today that the US Food & Drug Administration (FDA) has approved the Nucleus CI422 with Slim Straight Electrode, the newest electrode in its broad portfolio of implantable hearing solutions. The Slim Straight, along with other Cochlear electrodes...

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