Cybersecurity

Security for Connected Medical Devices

By John Turner

…numbers. https://www.securityfocus.com/news/11455 HIPAA Journal. Stolen Electromygraphy Device Contained 836 Patents PHI, says SSM Health. https://www.hipaajournal.com/stolen-electromyography-device-contained-836-patients-phi-says-ssm-health-8822/ Wikipedia. IEC 62304. https://en.wikipedia.org/wiki/IEC_62304 UL. FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices. https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/…

…numbers. https://www.securityfocus.com/news/11455 HIPAA Journal. Stolen Electromygraphy Device Contained 836 Patents PHI, says SSM Health. https://www.hipaajournal.com/stolen-electromyography-device-contained-836-patients-phi-says-ssm-health-8822/ Wikipedia. IEC 62304. https://en.wikipedia.org/wiki/IEC_62304 UL. FDA Recognizes UL 2900-1 Cybersecurity Standard for Medical Devices. https://www.ul.com/inside-ul/fda-recognizes-ul-2900-1-cybersecurity-standard-for-medical-devices/…

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FDA

FDA Publishes FDARA Mandated Report on Servicing of Medical Devices

By MedTech Intelligence Staff

…that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths)…

…that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths)…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Inspection Equipment not Qualified Equates to Problems with FDA!

By Dr. Christopher Joseph Devine

…all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results according to…

…all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results according to…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Diseases of the Kidney on Rise Across Asia

By Ames Gross

…The opportunities for expansion are greatest in dialysis care, continuous renal replacement therapy, and HIFU technologies, and the market is expected to grow fastest in Japan, Korea, Singapore and other…

…The opportunities for expansion are greatest in dialysis care, continuous renal replacement therapy, and HIFU technologies, and the market is expected to grow fastest in Japan, Korea, Singapore and other…

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Tobias Gilk, Metrasens, MRI
MEDdesign

Closing the Loopholes in MRI Safety: Using Ferromagnetic Detections Systems to Prevent Projectile Events

By Tobias Gilk

…first version of what is internationally recognized as the premier best practice guidance document, MRI projectile events have not completely gone away—just this past January in Mumbai, a man died…

…first version of what is internationally recognized as the premier best practice guidance document, MRI projectile events have not completely gone away—just this past January in Mumbai, a man died…

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BSL2 laboratories, Starfish Medical, University of Victoria

Rapidly Changing POC Assay Development Opportunity

By Nick Allan

…an aid in the diagnosis of infectious disease, due to its ability to deliver quick, actionable results while the healthcare provider still has access to the patient being tested. Major…

…an aid in the diagnosis of infectious disease, due to its ability to deliver quick, actionable results while the healthcare provider still has access to the patient being tested. Major…

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FDA

FDA Releases Draft Guidance for Multiple Function Devices

By MedTech Intelligence Staff

aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples. Industry can submit comments…

aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples. Industry can submit comments…

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magnifying glass

Two New Accounting Standards Disrupting Medical Device Companies

By Dennis Howell, Jeffrey Ellis

…impact of potential new contracts with customers. Changes in: Revenue Recognition The new FASB revenue standard effective for public companies this year requires medical device companies to comprehensively reassess their…

…impact of potential new contracts with customers. Changes in: Revenue Recognition The new FASB revenue standard effective for public companies this year requires medical device companies to comprehensively reassess their…

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China

In Vitro Diagnostics Registration and Reimbursement in China

By Ames Gross

test is, how the test is superior to others, reagent costs, equipment depreciation, test costs, and so on. The bureau will also seek feedback from key opinion leaders. The reimbursement…

test is, how the test is superior to others, reagent costs, equipment depreciation, test costs, and so on. The bureau will also seek feedback from key opinion leaders. The reimbursement…

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