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Re: MetalMarc post# 4634

Friday, 01/08/2016 10:15:17 AM

Friday, January 08, 2016 10:15:17 AM

Post# of 5090
Well it has been a long time coming ... but product certification is finally complete.

https://finance.yahoo.com/news/spine-injury-solutions-inc-receives-134500963.html
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Spine Injury Solutions, Inc. Receives Notice of Its Quad Video HALO™ Compliance in Accordance With EN 60601-1:2006 + A12:2014 Along With 2006/95/EC for CE Mark

Quad Video Halo, Inc., through its wholly owned parent company, Spine Injury Solutions, Inc. received notice on Dec. 30, 2015 from Professional Testing (EMI), Inc. of successful completion of compliance testing of the Quad Video HALO System to meet EN 60601-1 safety standard for medical equipment. The system also passed the IEC 60601-1-2 electromagnetic compatibility standard in September. This testing addresses the requirement of the EU Low Voltage Directive (2006/95/EC) for the CE mark.

HOUSTON, Jan. 08, 2016 (GLOBE NEWSWIRE) -- Houston based Spine Injury Solutions, Inc. (SPIN), a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, is pleased to announce that its Quad Video HALO (QVH), a video transparency accessory for medical fluoroscopy devices specifically designed for general Operating Room (OR) Video, Audio and other OR Data compilation, has now completed requirements for sales and marketing of medical applications under both US and EU standards.

Dr. William Donovan, CEO of Spine Injury Solutions, said, "Over the last few years, SPIN has invested significant time and money in the development of the QVH, a proprietary medical real-time video and documentation accessory. The QVH has undergone rigorous internal testing and has been used to great success in conjunction with SPIN's medical affiliates in a diagnostic program for treating more than a thousand spine injury cases. The QVH not only provides protection for the medical provider, through secure video transparency and real-time documentation of the procedures, but also gives great comfort to the patient knowing his or her medical provider will 'do his best' in performing the procedure."

Donovan went on to say, "Two years ago we realized the potential of the QVH. And, that with modifications, it could be expanded dramatically outside our own needs, not only for use with the tens of thousands of fluoroscopes (both fixed and portable) currently in service, but also in operating rooms world-wide. As a new player in the very competitive medical device and accessory space, we felt it was first imperative to have a patent (US Patent #US9,084,577 B2) on the QVH before openly entering the market. Once the final decision was made to market the applications externally, due to its use in a medical environment, outside certification/safety testing then became mandatory. From various trade shows and other sources, we quickly found that there was considerable interest in the QVH, particularly in teaching environments in Europe. This then required additional testing for the “CE” Mark which would allow QVH to sell in the 30+ EU member countries. With the successful completion of required testing and commensurate tax on both Management time and resources behind, along with the strong patent we received last July, I look forward to a very exciting and productive year ahead, in both our core and technology businesses.”

David Spencer, President of QVH added, “Spine Injury Solutions, Inc. has endured a long, arduous process to obtain these certifications. The combination of our patent and these certifications only proves our dedication to high standards and quality. We also have been in discussions with various groups about sales, leasing and marketing of the QVH both in the USA and Europe with focus on Teaching Hospitals, Pain Management Groups, Factoring Companies, who deal with Personal Injury A/R cases, ER/ Urgent Care Centers and Hospitals. The HALO Rx unit, a part of QVH, has been gaining attraction in operating room environment various types of surgeries recording in the applications in Video recording of different specialized types of Surgeries.”

Additionally from Spencer: “Over the past 3 years, Spine injury Solutions, Inc. had developed the QVH to provide Transparency for Pain Intervention procedures. This has been a win/win situation for patients and providers. In addition to providing liability protection for both patient and provider, now Teaching Hospitals have expressed significant interest in the QVH to assist in training programs. We have also been contacted by several medical Implant/Hardware companies expressing interest to use the QVH as a teaching tool for Doctors and Surgeons in the use of their new Surgical Techniques and Devices.”
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Amigo Mike