Mark V. Kingsley02/09/2021 The concept of applying ultrasound to neuronal activity for research and treatment has been around since as early as 1958. However, this promising speculation is now becoming a reality. Following the Investigational Device Exemption (IDE) approval by the FDA of the use of deep brain stimulation (DBS), vagus nerve stimulation, and repetitive … Continue reading
G. Wayne Moore02/09/2021 There are four paths forward currently being pursued regarding the so-called “Right-to-Repair” issue specific to medical devices; regulation, litigation, legislation, and collaboration. The FDA- initiated 3rd Party Service Docket central to this issue began almost 5 years ago. So, what has happened since March of 2016? The FDA committed to draft a … Continue reading
Mark V. Kingsley02/09/2021 When I first came through Acertara’s doors, all I knew was that the company had something to do with ultrasound technology repair. While I enjoyed the few physics classes I took in high school and college, I was not overly familiar with the science of ultrasound. My only real association with it … Continue reading
About the Author, G. Wayne Moore:A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published … Continue reading
Interested in getting your “A Guidebook for Diagnostic Ultrasound Probe Troubleshooting”? Like/Follow Acertara on LinkedIn and we will send you a copy. https://www.linkedin.com/company/acertara/?viewAsMember=tru… Continue reading
About the Author, G. Wayne Moore:A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published … Continue reading
Last week Acertara introduced the ability to test the Philips X5-1 transducer element-by-element with our patented Atlas system. The X5-1 is a 2D matrix array transducer with more than 3,000 elements. According to the recent FDA Guidance and the American Institute of Ultrasound in Medicine (AIUM) Testing and Repair Statement, “transducer element checks are important … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 08/11/2020 Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. Most ultrasound manufacturers routinely specify ISO/IEC 17025:2017 accreditation for suppliers of testing and calibration services. This accredited testing also applies to validating the materials and processes used in transducer repair activities. ISO/IEC … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 08/11/2020 In the thousands of defective ultrasound probes we see each year at our probe repair laboratory the ones that are most easily preventable relate to an end-user using a non-OEM approved HLD chemical, or not following the OEMs cleaning protocol. During the COVID-19 pandemic there were many hospitals … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 07/14/2020 An ultrasound pulse consists of a range of frequencies, not a single frequency. For example, a pulse receive capture from a previously excited transducer element, shown as the black waveform in the diagram below (ATLAS probe testing device – www.acertaralabs.com), contains a wide range of returning echo frequencies … Continue reading