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Boston Scientific Elects Dr. Jessica L. Mega and Susan E. Morano to Board of Directors

By MedTech Intelligence Staff

Jessica L. Mega, MD, and Susan E. Morano have joined the Boston Scientific Corporation board of directors. Jessica L. Mega, MD Dr. Mega is the co-founder of Verily Life Sciences,…

Jessica L. Mega, MD, and Susan E. Morano have joined the Boston Scientific Corporation board of directors. Jessica L. Mega, MD Dr. Mega is the co-founder of Verily Life Sciences,…

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Vik Anantha

Data-driven Surgery: The Next Step in Improving Care and Operational Efficiency

By Vik Anantha

…US News & World Report “honor roll” for best care, the networks they belonged to showed substantial variation in care.[6] A recent study on practice variation in JAMA Health Forum…

…US News & World Report “honor roll” for best care, the networks they belonged to showed substantial variation in care.[6] A recent study on practice variation in JAMA Health Forum…

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FDA Announces Additional Steps to Modernize Clinical Trials

By MedTech Intelligence Staff

On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct…

On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct…

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AAMI and BSI Partner to Publish Guidance on Artificial Intelligence

By MedTech Intelligence Staff

The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial…

The Association for the Advancement of Medical Instrumentation (AAMI) and the British Standards Institute (BSI) have jointly published guidance documents on performing risk management for machine learning (ML) or artificial…

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Bret Ludwig, 3M
MEDdesign

Wearable Design Challenge: Stick-to-Skin Adhesion

By Bret Ludwig, Ph.D.

news for wearable device developers is, we have decades of experience and entire families of stick-to-skin PSAs to draw on as we attempt to address the latest challenges presented by…

news for wearable device developers is, we have decades of experience and entire families of stick-to-skin PSAs to draw on as we attempt to address the latest challenges presented by…

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Patrizia Cavazzoni, M.D.

FDA Releases Two Discussion Papers on Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers,…

On May 10, the FDA released two discussion papers on the use of artificial intelligence and machine learning (AI/ML) in drug development and manufacturing. In a statement introducing the papers,…

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Michael Marquardt

Implementing MedTech Price Increases in Times of Inflation and EU MDR

By Michael Marquardt

…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…

…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…

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CDRH Announces Radiation Sterilization Pilot Program

By MedTech Intelligence Staff

On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation…

On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation…

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