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ISO13485 Quality System affirmed for MelMedtronics

On Oct 31st, 2016 BSI officially affirmed that Melmedtronics operates its Quality Management System in compliance with ISO13485 for “Design, development, manufacturing and distribution of mobile software applications and devices for audiology assessment of hearing.”.
Marshall Wenrich, COO, restated that Melmedtronics is committed to enhancing it Products under full Design Controls for its entire International customer base.

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“This is the next step in finalizing our product registrations with Health Canada and meeting regulatory requirements for CE Mark. That combination will unleash all our established Distributors across a constantly expanding global marketplace.”

Dr. David Holmes, CEO at MelMedtronics


Melmedtronics already has international installations or trials in process across 32 countries outside the United States on six continents.

“The software technology used to develop our iAudiometer and Tele-iAudiometer allows us to easily accommodate localization requirements including language options, labeling and unique regional processing subtleties. And of course the base tone generation engine of all our products is already calibrated to the accepted international ANSI Standards (ANSI S3.6) and ISO-EN Standards (EN60645)”

Dr. Gianna Lardaro, CPO at MelMedtronics

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Anyone requiring additional information about Melmedtronics’ ISO13485 Quality System or regulatory status in various countries can contact info@melmedtronics.com


Interested in becoming a Distributor in Melmedtronics global footprint, send email to distributor@melmedtronics.com

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Tele-iAudiometer™ International commercial launch announced

Our previously announced beta-testing for Tele-iAudiometer™ at multiple International sites including 32 countries outside the United States on six continents has concluded with a lot of field usage data, some great suggestions that have already been incorporated and more recommendations that will appear in future software releases.

We thank all our participants for your huge enthusiasm and active engagement!

Therefore, Melmedtronics is announcing International (ex-USA) commercial availability of the Tele-iA Product starting July 29th for all continents other than North America.

Marshall Wenrich, COO, explained the launch strategy:

We still have significant beta-site testing ongoing in the United States with Government agencies and very large Clinic operators. All of those sites are actively contributing to tele-iA refinements for those target markets, however the ultra-low cost of initial entry to gain diagnostic access to traditionally unreachable locations has resulted in our international Distributors pleading for access to the Commercial Product version.

 
The introduction of ISB-mini as an extremely light weight functional equivalent that replaces our Standard ISB in a much smaller package enables our initial tele-iA Product launch for highly mobile environments. And unlike the manufacturing production problems that slowed iA System deliveries during second quarter this year, ISB-mini is available in quantity right now.

Tele-iA is sold as a highly-configurable ‘service’ with an upfront initial equipment cost and monthly fee for the features provided. According to Dr Gianna Lardaro, CPO,

Tele-iAudiometer comprises two software components on two separate platforms: one on the Doctor Site acting as a remote controller, and one on the Patient Site acting as the audiometer. The latter uses the same proven engine of iAudiometer so it is also calibrated to ANSI Standards (ANSI S3.6) and ISO-EN Standards (EN60645): this makes Tele-iAudiometer a full diagnostic tele-audiology system where a single Clinician device can operate equipment at multiple (remote) Patient sites.

 

Many philanthropic organizations have been the perfect outreach mechanism to validate remote usage and have independently documented benefits from using the iAudiometer technology during mission trips.



©Copyrights Hear The World Foudation

Hear the World volunteers were able to complete the free hearing tests, thanks to donated Insert ear phones and iPad software [….]the iAudiometer testing software for the ear conduction screenings at the public health fair.

For Tele-iA pricing in your specific region, contact your Distributor or Melmedtronics directly for a customized quotation. There are no long-term contracts and the selected services may be adjusted through the Melmedtronics’ customer web portal on a monthly basis to optimize the return on investment as needs change.

Interested in becoming a Distributor in our global footprint, send us email at distributor@melmedtronics.com.
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MelMedtronics closes pre-order period

MelMedtronics closes pre-order period and confirms generalcommercial availability for two Product families: ISB & iAudiometer Systems

MelMedtronics would like to thank everyone for the overwhelming response to our pre-order period discount sale. Orders received through the end of May 24th are currently being calibrated and prepared for delivery shipment dates within the next 7-10 days. Those Professionals in Audiology fields that have become early adopters of our technology will continue to be rewarded with discounts on our future products!
    
"As we shift our Product Development attention to the planned July launch of remote Tele-iA services, we are incorporating valued suggestions from Clinicians who are active in our Tele-iA Beta-testing program. Those feature enhancements will initially be available with Tele-iA deployments, and we will very quickly release an equivalent feature set for our current standalone iA Systems. The two product families serve different purposes, but each is designed to be highly mobile, clinically accurate and easy to use for anyone in Audiology testing fields."
Dr Antonio Curci, CTO at MelMedtronics.

iAudiometer System: like other audiometers in the market, iA System comes complete with calibration and transducers, but unlike other audiometers, iA brings all the efficiency and portability of an ultra-light weight iPad as the heart of the audiometer. Compare models on our website to match your way of using a mobile iPad-based audiometer.
  

Interface Switch Box*
 allows directly connecting the iPad to multiple audiometric transducers and easily switch between them, without plugging and unplugging.
The ISB comes in two models:
    
ISB: Ideal for people who use our portable iA System outside the office or in a mobile setting within a facility. Never plug and unplug transducers anymore while performing tests.
    
ISB+: Fits the needs of connecting the iAudiometer to the SoundBooth with optimal fidelity, and at the same time conveniently connects AC transducers, BC transducers and SoundField Speakers. ISB+ allows Professionals to utilize Talk-Back and Talk-Over during testing.
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MelMedtronics opens pre-orders of ISB & iAudiometer Systems

MelMedtronics announces the opening of pre-orders for two new much-anticipated Products: ISB & iAudiometer Systems

MelMedtronics is focused on Professionals in Audiology fields; their continuous participation in conveying industry needs has led to major improvements in the design of these two Products, further advancing the disruptive and innovative attitude of the company.
    
"This is a very important day for the company. We’re moving fast, achieving multiple milestones along the way, yet totally determined to enable hearing assessments for previously undiagnosed Patients by overcoming geographical barriers. The entire team is so proud to be at the head of this important and disruptive moment in the audiology field!"
Dr David Holmes, CEO at MelMedtronics

Interface Switch Box*
 allows directly connecting the iPad to multiple audiometric transducers and easily switch between them, without plugging and unplugging.
The ISB comes in two models:
    
ISB: Ideal for people who use our portable iA System outside the office or in a mobile setting within a facility. Never plug and unplug transducers anymore while performing tests.
    
ISB+: Fits the needs of connecting the iAudiometer to the SoundBooth with optimal fidelity, and at the same time conveniently connects AC transducers, BC transducers and SoundField Speakers. ISB+ allows Professionals to utilize Talk-Back and Talk-Over during testing.

Interface Switch Box can be pre-ordered at 25% promotional discount price


iAudiometer System: now Professionals can choose between 4 different models to match their own way of using a mobile iPad-based audiometer. Like other audiometers in the market, iAudiometer System comes complete with calibration and transducers, but unlike other audiometers, iA still brings all the innovation and portability of an ultra-light weight iPad as the heart of the audiometer.   

iAudiometer can be pre-ordered at 25% promotional discount price

"Professionals have asked for and will love the ISBs: this design complements the ease of use, innovation and portability of our iAudiometer, making them the perfect hi-fidelity match for our iPad-based audiometer. More so, iA System was conceived to minimize setup time in the field by simplifying steps to begin testing with the iPad audiometer. This is another step forward towards Tele-iAudiometer that will be launched this July!"
Gianna Lardaro, CPO at MelMedtronics
Pre-order will end on May 24th and products will be scheduled for shipping starting on May 25th on a first-come, first-served basis, so don't hesitate to visit our eShop. Delivery is approximately 7-10 days after payment is received.
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MelMedtronics announces the release of its beta Tele-iAudiometer™

MelMedtronics announces the worldwide release of its beta Tele-iAudiometer™ iOS app.
This is the world’s first Tele digital audiometer on mobile devices that includes video communications, a full range of audiological tests, and built-in analytics.

 

This Is An Exciting Opportunity For Audiologists To Economically Enter The Telehealth Space Using Our Tele-iAudiometer Solution With A Customizable Suite Of Options.
Jon Putman, VP Sales at MelMedtronics
Tele-iAudiometer scheme.001

 

Our Telemedicine system will allow Audiologists to complete hearing exams remotely without geographic boundaries”
Dr David Holmes, CEO at MelMedtronics

 

The company is currently enrolling beta sites now through April 11th to immediately start using the Tele-iAudiometer system in their practice, in exchange for providing valuable insights back to MelMedtronics design team prior to the mid-Q2 2016 official product launch.
Interested parties wanting to innovate within their facility or practice should contact MelMedtronics VP of Sales, Jon Putman at jon.putman@melmedtronics.com.
Key Features of Tele-iAudiometer™:
  • HIPAA Compliant
  • Meets ANSI and ISO EN Standards
  • No Servers needed and No IT Configurations required
  • Compatible with Broadband, Cellular and Satellite Connections
  • EHR Integration
  • 4 minutes Installation Time
  • and much more…
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MelMedtronics completes registration its Products with FDA

Registered FDA

MelMedtronics announces completion of its medical device registration with FDA. The product line is showcased by the world’s first Tele digital audiometer on mobile devices, Tele-iAudiometer that includes video communications, a full range of audiological tests, and built-in analytics.

We are able to highly leverage our proprietary software platform approach for Telehealth to economically create targeted products with a Customizable Suite of Options. Although the initial products are iOS-centric, we are in the process of down-selecting a set of EHR systems from which we can import/export patient and doctor information directly, including supporting the industry standard NOAH format.

Gianna Lardaro, Chief Products Officer at MelMedtronics

The establishment registration and full list of products is available on the FDA website by clicking the following link:

Establishment Registration & Device Listing

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The FDA Registration is a big step forward For MelMedtronics.
We also have a pending Application for Health Canada and are in the process of renewing our ISO:13485 and our CE Mark for the EU!

Dr. David Holmes, CEO at MelMedtronics

For more information on testing or acquiring our products, interested parties should contact MelMedtronics VP of Sales, Jon Putman at jon.putman@melmedtronics.com.

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MelMedtronics announces its new Chief Operating Officer

MelMedtronics is very proud to announce that Marshall Wenrich has been appointed as Chief Operating Officer.

Mr. Wenrich said:

“I am so impressed that Melmedtronics has launched this specialized area of diagnosis and treatment into the 21st century through an effective use of modern technology. MelMedtronics is riding a huge industry trend and I’m grateful to have the opportunity to join with them in furthering that ambition!”.

Mr. Wenrich will be focused on scale-up of the entire organization including overseeing the day to day operations of the company, improving operating procedures to allow the company to serve multiple diverse end customers, supporting Marketing/Sales in the dissemination of the unique Melmedtronics’ Brand, and coordinating use of funds to advance other product development initiatives. MelMedtronics believes the addition of Wenrich rounds out the mangement team and will leverage his significant medical device history to accelerate company growth.

More about Marshall Wenrich (Visit his LinkedIn Profile)

Marshall is a Technology-oriented operations Executive with a 24-year history serving as CEO/COO, Management Consultant, or Board Member in support of growth plans leveraging innovation to significantly increase company valuation. As an active member in the NACD continuing education program, Marshall has identified how his experience operating and growing high-tech companies can be integrated with existing Board of Directors/Advisors as an independent, yet practical perspective. He has personally worked with more than 200 companies on products across medical, avionics, information technology, communications and industrial control ranging from start-ups to Tier 1 stalwarts.
Marshall received his BS in Engineering at Lehigh University and MS in Engineering at University of Texas.
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A new research comparing effectiveness of the tablet audiometry

Audioprotesista

Published on l’Audioprotesista* (July ’15)

A new research comparing effectiveness of the tablet audiometry

iAudiometer : a new step forward in digital audiology. A comparative effectiveness and screening research

Visit our Studies page to read the article. 

Many thanks to Dr. Lucio Vigliaroli and Dr. Francesco Parrella for that wonderful research!

* www.audioprotesista.it – official organ of Italian Audiologists

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