dimarts, 27 de novembre del 2018

Sonova licenses Ceva’s RivieraWaves Bluetooth tech for Sword 3.0 hearing aid chip

Sonova

Sonova Holding AG (SIX:SOON) has inked a deal to license Ceva’s RivieraWaves Bluetooth intellectual property for use in its Sword 3.0 wireless hearing aid chip, Ceva said today.

The licensed RivieraWaves Bluetooth IP platform consists of a hardware baseband controller and software protocol stack and will help power the Sword 3.0, which Sonova touts as the world’s first and only hearing aid radio chip that will fully support direct binaural streaming of audio content.

“We are delighted to formally announce our partnership with Sonova, for our RivieraWaves Bluetooth IP. It’s a testament to the quality of our Bluetooth technology for even the most stringent use cases and we look forward to continuing our work together as Bluetooth looks set to become the wireless standard of choice for hearing aids and other smart hearing devices,” CEVA connectivity biz GM Aviv Malinovitch said in a prepared statement.

The Sword 3.0 device is intended to connect to a smartphone for internet access that will allow the devices to be adjusted remotely by their hearing care professional, the companies said.

“Our latest generation Sword chip reinforces our mission to continually introduce new and innovative technologies that greatly improve the user experience of hearing aids. The integration of CEVA’s advanced Bluetooth Dual Mode IP into our wireless chip enables us to bring low power stereo audio streaming and data connectivity to our hearing aids, giving our customers an unparalleled user experience,” Sonova wireless R&D director Marc Secall said in a press release.

In August, Sonova subsidiary Advanced Bionics said that it won FDA approval for its HiRes Ultra 3D cochlear implant.

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Webinar: Here are the medical device outsourcing challenges you need to avoid

medical device outsourcing

Constant cost pressures – coupled with increased expectations to reduce time to market – often require medtech manufacturers to outsource all or part of their device assembly.

Medical device outsourcing allows a medtech company or startup to focus on its core competencies. But cost containment and speed to market aren’t everything: They represent just a few of the factors to take into account before committing to a manufacturing partner. That’s especially when it comes to producing quality medical devices.

From the common pitfalls to assessing an outsourcing partners’ vertical integration capabilities, this webinar will outline the many factors you should consider before engaging a medical device outsource manufacturer to ensure your company can scale for growth and better meet market demands.

Tuesday, Dec. 4, 2018
11:30 a.m. Eastern time / 8:30 a.m. Pacific time

 

 

Featured Speakers:

Joe Flanagan
EVP Quality & Regulatory
Integer

 

 

 

Mike Druding
Senior Director, Engineering  
Integer

 

 

Chris Newmarker
Managing Editor
Medical Design & Outsourcing

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United Orthopedic wins FDA nod for E-XPE hip liner

United Orthopedic Corp said today that it won FDA clearance for its E-XPE vitamin E highly cross-linked polyethylene hip liner.

The Irvine, Calif.-based company said that the E-XPE is a next-gen version of its highly cross-linked polyethylene blended with vitamin E intended to improve wear resistance and maintain oxidative stability and mechanical properties.

United Orthopedic said that accelerated aging tests showed that its E-XPE inserts and liners exhibited a 60% to 75% reduction in gravimetric wear, respectively.

“Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements. Clearance of our E-XPETM, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry,” prez Calvin Lin said in a press release.

Last May, United Ortho said that it launched a trial of its U2 total knee arthroplasty system and enrolled the 1st patient in the trial.

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Sterility assurance tech dev Verrix raises $8m in Series B

Verrix

Sterility assurance device developer Verrix said today that it raised $8 million in a Series B round of financing, lifting the total the company has raised so far to $17.5 million.

The San Clemente, Calif.-based company said that funding from the offering will support finalizing the development, regulatory submission and eventual commercialization of its Verrix EVA biological indicator system.

Verrix said that the system is intended to verify the success of sterilization cycles and to detect failures, and comes based off technology originally developed at NASA’s Jet Propulsion Laboratory.

The company added that it is aiming for a launch of the first BI system based on its technology some time next year.

“We are excited to see the rapid advancement of Verrix with strong support from our investors. The company has achieved significant progress in the development of the Verrix EVA BI System and is well positioned to successfully transition to commercialization as it prepares to introduce new technology for the fight against hospital acquired infections,” CEO Cameron Rouns said in a press release.

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Paradigm Spines wins Coflex coverage from AmeriHealth Caritas

Paradigm Spine

Paradigm Spine said today it won coverage for its Coflex interlaminar stabilization device intended to treat lumbar spinal stenosis from AmeriHealth Caritas.

The Coflex interlaminar stabilization system is the New York-based company’s flagship device, and is designed for posterior lumbar preservation in patients with moderate to severe spinal stenosis.

With the coverage, an additional 5.3 million individuals will be able to receive treatments with the Coflex device, the company said.

“With this continued payor coverage momentum, we look forward to further expanding access to our Coflex solution, which is backed by more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, and spine medical society guidelines,” chair & CEO Marc Viscogliosi said in a press release.

Earlier this month, RTI Surgical (NSDQ:RTIX) agreed to put $300 million on the table for Paradigm Spine and its Coflex lumbar stenosis device.

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6 exhibitors at DeviceTalks West you should know

DeviceTalks-West-2018DeviceTalks West is an annual event that allows some of the best minds in medtech to exchange ideas, insights and technologies.

Medical Design & Outsourcing’s parent company WTWH Media holds DeviceTalks annually in Boston, Orange County, Calif., and the Twin Cities in Minnesota. It is hosted by MassDevice and attendees can plan to enjoy networking with people in medtech, in-depth interviews with leaders in the industry, panel discussions about medical devices and more.

The event also houses a number of exhibitors who will be showcasing some of their hot technologies and services at the event. Here are six exhibitors at DeviceTalks West this year that you should check out.

Next >>

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Propeller Health touts link between air pollution, rescue inhaler use in nationwide asthma study

Propeller Health

Propeller Health today touted results from a nationwide study that indicated a direct association between daily air pollution and rescue inhaler use.

Results from the study, which spanned five years and involved more than 2,800 individuals with asthma, were published in the Proceedings of the National Academy of Sciences, the Madison, Wisc.-based company said.

Read the whole story on our sister site, Drug Delivery Business News

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