medical instrument News
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The state drug administration issued five medical devices regulations
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, on the basis of demonstration, solicit opinions from all sides, and ...
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Medical certification obtained for the products of the Vaud startup
SteriLux passes the course of medical certification for the European market, thus demonstrating that its technology meets the most demanding standards in the field of health. Sterilizing heat-sensitive medical instruments without chemicals: this is the objective that the Vaud-based startup SteriLux has set itself since its creation in 2014. Its product, of sustainable design, uses ...
By SteriLux SA
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Seno Medical and “Know Your Lemons” Team Up For Breast Cancer Education
Seno Medical Instruments, Inc. (Seno Medical), a Texas-based medical imaging company developing breakthrough breast cancer diagnostic technology, announced an educational partnership supporting Worldwide Breast Cancer’s “Know Your Lemons” campaign starting with the Netherlands, which has one of the highest breast cancer incidence rates in the world. Through the partnership with ...
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Poster Presentation at RSNA Compares Seno Medical’s OA/US Breast Imaging with AI Decision Support to Ultrasound Alone; Finds Significantly Better Specificity to Support Clinical Decision Making Conf
A study presented at the Radiological Society of North America (RSNA)’s annual meeting showed Texas-based Seno Medical Instruments, Inc. (Seno)’s Imagio opto-acoustic ultrasound (OA/US) breast imaging provides significantly better specificity than ultrasound alone. The poster, “Performance of Optoacoustic Ultrasound with an Artificial Intelligence-based Decision Support Tool vs ...
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Electronic Control Security, Inc. names Robert Oliver as vice president, operations.
Electronic Control Security, Inc. (OTC Bulletin Board: EKCS.OB) (ECSI) (www.ecsiinternational.com), a global leader in entry control and perimeter security systems, today announced the appointment of Robert Oliver as Vice President, Operations. Arthur Barchenko, President of ECSI, stated that “Robert will fill an important position in the Company to meet the growing demand for its products ...
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Seno Medical Launches CONFIDENCE Registry Study for Imagio® Breast Imaging System
Texas-based Seno Medical Instruments, Inc. (Seno) has launched its CONFIDENCE registry to evaluate the efficacy of imaging with opto-acoustic/ultrasound (OA/US) to diagnose breast abnormalities including cancer using its groundbreaking Imagio® Breast Imaging System. Approximately twelve sites will participate in the international registry, with a target of over 600 total patients ...
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Guided Therapeutics Announces Testing Completion of First 150 Patients in Chinese Clinical Study and Receives Milestone Payment of $177,740
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, announced today that testing of 150 patients has been completed in the ongoing clinical trial for Chinese National Medical Products Administration (NMPA) approval. The trial is underway at four sites in China. The trial is expected to be completed in the second quarter of this year and submitted for approval ...
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Seno Medical and “Know Your Lemons” Highlight Importance of Education and Self-Exam for Early Breast Cancer Detection
A recent survey of women in the Netherlands found that 79 percent of respondents diagnosed with breast cancer noticed symptoms prior to being diagnosed. Seno Medical Instruments, Inc. (Seno Medical), a Texas-based medical imaging company developing breakthrough breast cancer diagnostic technology, teamed up with the Know Your Lemons campaign to conduct the survey in the Netherlands, which has ...
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FDA Approves Seno Medical’s Ground-Breaking Breast Cancer Diagnostic Technology
The Center for Devices and Radiological Health (CDRH) of the US Food & Drug Administration (FDA) has granted Texas-based Seno Medical Instruments, Inc. (Seno) premarket approval (PMA) for its groundbreaking diagnostic breast cancer imaging technology that helps physicians better differentiate between benign and malignant breast lesions. The company’s Imagio® Breast Imaging System ...
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Additional Research Published In Radiology Demonstrates Application Of Ground-Breaking Breast Cancer Diagnostic Technology
An article recently published in Radiology highlights the groundbreaking use of a new imaging technology introduced by Seno Medical Instruments, Inc.® (Seno Medical) to diagnose breast cancer. The technology may offer physicians a new, non-invasive tool to not only better differentiate between benign and malignant breast cancers, but may also help differentiate between breast cancer molecular ...
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Multiple Publications and Presentations Underscore Seno Medical’s Value Proposition in Mitigating the Cost and Burden of Unnecessary Breast Biopsies
Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic ultrasound (OA/US) imaging to differentiate benign from malignant masses, today provided a summary of key 2018 data publications and presentations that demonstrate the clinical utility and healthcare economic benefits of its proprietary, cutting-edge technology. ...
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European Radiology Profiles Seno Medical’s Ground-Breaking Breast Cancer Diagnostic Technology
Additional research appearing in the June online issue (open access) of European Radiology features the groundbreaking diagnostic breast cancer imaging technology introduced by Seno Medical Instruments™, Inc. (Seno Medical). This technology might not only help physicians better differentiate between benign and malignant breast lesions, but also discriminate between breast cancer molecular ...
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New Data Demonstrate That Seno Medical’s Opto-Acoustic Imaging Technology Offers A Non-Invasive Approach to Differentiating Breast Cancer Molecular Subtypes
Seno Medical Instruments, Inc. (Seno Medical), the leader in new technology for breast cancer diagnosis using opto-acoustic (OA/US) imaging to differentiate benign from malignant masses, reported results of a study demonstrating that morphologic and functional OA/US features provide a non-invasive approach to helping distinguish breast cancer molecular subtypes. The data were presented on ...
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STEMart Announces Pilot Production Services for Medical Devices
STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Pilot Production Services for the medical device industry. These services allow manufacturers to test and refine their products prior to full-scale production, streamlining the development process of new medical devices and minimizing risk to save time ...
By STEMart
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Robocath bolsters Strategic Committee with appointment of Chantal Le Chat as independent member
Chantal boasts 35 years of skill and know-how built up while working a range of posts at imaging major player GE Healthcare. Over the last six years, she has occupied key strategic roles in the company’s Interventional Division, including Global GM. Her duties as an independent member of the Strategic Committee will include supporting the governance of Robocath. She will use her extensive ...
By Robocath
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Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing Center of the State Food and Drug ...
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STEMart Launches Biological Indicator Sterility Testing Service for Medical Devices
STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Biological Indicator Sterility Testing services for the industry of medical devices. This testing is performed according to the exposure of Biological Indicators (BIs) after completion of the sterilization load, and it is a qualitative test to reveal results that can ...
By STEMart
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Daxor Announces Prospective Randomized Control Trial at Duke University Medical Center to Guide Volume Treatment in Heart Failure Patients
Daxor Corporation (NYSE MKT: DXR), an investment company with innovative medical instrumentation and biotechnology operations focused on blood volume measurement, today announced the initiation of a prospective randomized control trial (RTC) utilizing Daxor’s BVA-100 (Blood Volume Analyzer, “BVA”) technology to guide volume treatment in heart failure patients. Duke University ...
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Guided Therapeutics Announces Start of Chinese Clinical Trial for Approval to Market and Sell LuViva in China
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, announced today that enrollment and testing of patients has begun at the Department of Obstetrics & Gynecology Hospital of Fudan University located in Shanghai. The data will be submitted to the Chinese National Medical Products Administration (NMPA; formerly ...
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ASTM F1855 - 00(2011) Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. Physical and mechanical properties of medical grade ...
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