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The Role of Computational Simulation in Modeling Fluidic-based Cassettes for POC Devices

Leave a Comment / 04-Product Design & Development, computational simulation, diagnostics, manufacturing, Medical Device, MedTech, point of care devices, RC - Device Design & Manufacturing / By

The Role of Computational Simulation in Modeling Fluidic-based Cassettes for POC Devices     The rising incidence of infectious diseases has acted as a driving force for the accelerated development of precise, decentralized and cost-effective diagnostic technologies. Within this landscape, point-of-care (POC) devices stand out as game-changing instruments, capable of delivering quick and accurate diagnoses right …

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Precision Medicine Meets AI: Advances in Cough Monitoring

Leave a Comment / 01-Digital Health, AI/ML, artifical intelligence, Care Delivery, Clinical Decision Support, diagnosis, diagnostics, Medical Device, MedTech, Soapbox / By

Precision Medicine Meets AI: Advances in Cough Monitoring     Cough is a common and, at times, problematic medical condition that is ripe for disruption. It is one of the main reasons why patients seek medical care. In Europe and the U.S., between 9% and 33% of the population reports cough at any given time; and …

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Veranex Acquires Fusion Biotec

Leave a Comment / diagnostics, engineering, Medical Device, medical device design, MedTech, Product Design & Development / By

Veranex Acquires Fusion Biotec     Global, tech-enabled service provider to the MedTech industry Veranex has acquired Fusion Biotec, a design and engineering firm for complex electro-mechanical diagnostic instrumentation and medical devices located in Orange, California. Fusion boasts a 15,000-square-foot facility in Orange, California, and an in-house team of more than 45 engineering experts, who largely serve …

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Lace To Helm New RQM+ Reimbursement Division

Leave a Comment / diagnostics, managed care, Market Access, Medical Device, MedTech, product lifecycle, reimbursement / By

Lace To Helm New RQM+ Reimbursement Division     RQM+, a global MedTech regulatory and quality service provider, has launched a reimbursement division to provide its clients with reimbursement services, in addition to regulatory, quality, clinical and laboratory services, throughout the medical device and diagnostics product lifecycle. Daniel Lace, MD, will lead the new division and …

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WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight 

Leave a Comment / communicable disease, diagnostics, Disease X, henipaviral disease, Medical Device, MedTech, MedTech Economics, MERS, pathogens, Rift Valley fever, SARS, vaccines, WHO, Zika / By

WHO Convenes Panel to Identify Priority Pathogens for Research and Oversight      The World Health Organization (WHO) announced that it is launching a global scientific process to update the list of priority pathogens to guide global investment, research and development of vaccines, tests and treatments. The process began on November 18 with a meeting of …

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The Real Impact of IVDR on Clinical Evidence Requirements

Leave a Comment / benefit risk, clinical evidence, diagnostics, EU, Focus Article, IVDR, Medical Device, MedTech, notified bodies, patient protection, precision medicine, Quality/Regulatory, RC - EU MDR and IVDR / By

The Real Impact of IVDR on Clinical Evidence Requirements     For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …

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American Health Care Has a Diagnostics Problem

Leave a Comment / diagnostics, drug approval, evidence-based, evidence-informed, mammograms, Market Access, Medical Device, MedTech, Prenuvo, Soapbox, U.S. health care / By

American Health Care Has a Diagnostics Problem     As everyone knows, America has among the world’s highest healthcare costs, spending $4.1 trillion per year—about $12,500 per person, or three times the OECD average. But another aspect of our health system gets far less attention: our focus on reactive treatment instead of proactive diagnostic and preventive …

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