VANCOUVER, BC and BOSTON, MA--(Marketwired - October 06, 2016) - Imagin Medical (CSE: IME) (OTC PINK: IMEXF) (FRANKFURT: DPD2) (the "Company") announced today that the Company's Quality Plan for compliance with U.S. FDA regulations and International Standard ISO 13485 has been approved by the Company's management team.
The Quality Management System (QMS) will detail the generation and management of all the Company's standard operating procedures, Design History File documents, and all quality records to support the development of the i/Blue Imaging system for the detection of bladder cancer. Design control procedures have been developed and implemented to support and document the prototype development underway at the University of Rochester's Laboratory for Laser Energetics.
During the coming months, the Company's QMS will be expanded to build and document pilot production units in support of initial bench testing and potential pilot clinical studies. Advanced manufacturing documentation for eventual commercialization will be developed as well.
According to Steve Ruggles, Director of QA / RA, "Imagin has assembled a team of brilliant scientists, doctors, engineers and seasoned medical device management professionals. Our devices will be designed, tested and manufactured in strict compliance with all design, risk management and documentation requirements of the U.S. FDA and other international regulatory bodies for worldwide marketing."
About Imagin Medical
Imagin Medical is developing imaging solutions for the early detection of cancer through the use of endoscopes. The Company believes it will radically improve the way physicians detect cancer. Imagin's initial target market is bladder cancer, a major cancer worldwide, the sixth most prevalent in the U.S., and the most costly cancer to treat due to a greater than 50% recurrence rate. Developed at the Lawrence Livermore National Laboratory, this advanced, ultrasensitive imaging technology is based upon improved optical designs and advanced light sensors. Learn more at www.imaginmedical.com.
ON BEHALF OF THE BOARD:
President & CEO
Information set forth in this news release contains forward-looking statements. These statements reflect management's current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company's control. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. The CSE has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.