Dror Kolodkin-Gal, Ph.D.
Soapbox

Improving Image Integrity in Clinical Research

By Dror Kolodkin-Gal, Ph.D.

…their reputations, publishers can avoid publishing problematic manuscripts with mistakes and the scientific community can better ensure the integrity of future research.   References: [1] https://www.economist.com/science-and-technology/2022/07/23/critical-research-on-the-causes-of-alzheimers-may-have-been-falsified [2] https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease [3] https://ukrio.org/research-integrity-resources/expert-interviews/jana-christopher-image-integrity-analyst/…

…their reputations, publishers can avoid publishing problematic manuscripts with mistakes and the scientific community can better ensure the integrity of future research.   References: [1] https://www.economist.com/science-and-technology/2022/07/23/critical-research-on-the-causes-of-alzheimers-may-have-been-falsified [2] https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease [3] https://ukrio.org/research-integrity-resources/expert-interviews/jana-christopher-image-integrity-analyst/…

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Sean Smith

The Real Impact of IVDR on Clinical Evidence Requirements

By Sean Smith

…on the market, provided the company commits with its notified body to complete further testing in the post-market phase as more tumor samples become available. However, “that is only in…

…on the market, provided the company commits with its notified body to complete further testing in the post-market phase as more tumor samples become available. However, “that is only in…

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Whitehouse 2021

White Houses Releases AI Bill of Rights Blueprint

By MedTech Intelligence Staff

…benefits brought about through the use of automated systems in agriculture, emergency preparedness and health care. “This important progress must not come at the price of civil rights or democratic…

…benefits brought about through the use of automated systems in agriculture, emergency preparedness and health care. “This important progress must not come at the price of civil rights or democratic…

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Doctor on computer

AHRQ Announces Real World Data Competition for HCOs

By MedTech Intelligence Staff

On September 27, the Agency for Healthcare Research and Quality (AHRQ) announced a new challenge competition to explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data…

On September 27, the Agency for Healthcare Research and Quality (AHRQ) announced a new challenge competition to explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data…

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Mother child and doctor

Ethical Considerations for Children in Clinical Investigations: FDA Publishes New Draft Guidance

The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the…

The FDA has published a new draft guidance that outlines its current views regarding ethical considerations for clinical investigations of medical products in children. The guidance seeks to balance the…

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Laura Jones
Soapbox

A Single Source of Truth Helps Regulatory Teams

By Laura Jones

…Real-time communication eliminates constant uploads and downloads. More accessible data also enables greater regulatory compliance capabilities through artificial intelligence (AI), allowing regulatory teams to quickly identify delays and conduct a…

…Real-time communication eliminates constant uploads and downloads. More accessible data also enables greater regulatory compliance capabilities through artificial intelligence (AI), allowing regulatory teams to quickly identify delays and conduct a…

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FDA

FDA Announces Funding Opportunities for Medical Device Development Tools

By MedTech Intelligence Staff

The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…

The FDA Center for Devices and Radiological Health (CDRH) has announced new funding opportunities to support small businesses in developing innovative medical device development tools (MDDTs). The MDDT program was…

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Mohamed Benkirane
MEDdesign

Raising the Bar on Quality for MedTech Production

By Mohamed Benkirane

…speeding up new product introductions and complying with increased regulatory requirements. Benefits of Predictive Quality Predictive quality is a proactive and adaptive approach to build quality into processes. It combines…

…speeding up new product introductions and complying with increased regulatory requirements. Benefits of Predictive Quality Predictive quality is a proactive and adaptive approach to build quality into processes. It combines…

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Veranex logo

Veranex Acquires Medidee

By MedTech Intelligence Staff

…The combined companies will offer a full spectrum of integrated concept-to-commercialization services, including design, engineering, regulatory, quality, preclinical research, clinical development, clinical operations, commercial strategy and market access services.  …

…The combined companies will offer a full spectrum of integrated concept-to-commercialization services, including design, engineering, regulatory, quality, preclinical research, clinical development, clinical operations, commercial strategy and market access services.  …

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MedExecWomen Panel on M&A

M&As: Maximizing the Partnership Process on Both Sides

By Leslie Storms, Kristine Ilaria, Martha Shadan

…experienced a particular strategy and mixture of tactics that accomplish M&A compatibility that is based on strong relationship fundamentals: trust, communication and “a match.” Both larger and smaller companies may…

…experienced a particular strategy and mixture of tactics that accomplish M&A compatibility that is based on strong relationship fundamentals: trust, communication and “a match.” Both larger and smaller companies may…

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