Sherry Parker, WuXi AppTec

Release Kinetics: An Important Element in Understanding Toxicological Risk of Chemical Constituents

By Sherry Parker, Ph.D.

…study focusing on a single compound of concern, but more often necessitates data generation through extractables/leachables (E/L) testing. For many medical devices, exhaustive and exaggerated extractions are recommended by ISO…

…study focusing on a single compound of concern, but more often necessitates data generation through extractables/leachables (E/L) testing. For many medical devices, exhaustive and exaggerated extractions are recommended by ISO…

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Inga Hansen, Managing Editor

Innovative Publishing Names Inga Hansen Managing Editor of MedTech Intelligence

…a digital media community for medical technology innovators, healthcare IT professionals, and industry regulators working to improve patient care and provide greater access to affordable, efficient healthcare. We inform, educate…

…a digital media community for medical technology innovators, healthcare IT professionals, and industry regulators working to improve patient care and provide greater access to affordable, efficient healthcare. We inform, educate…

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Bernstein_Mazur

Transforming Health Care: The Drive For Digital Health and Health IT

By Stephen Bernstein, Lisa Mazur

…healthcare technology, a busy regulatory environment and evolving consumer demands have combined to shape today’s digital health space. Examining the interplay of those factors can give us a glimpse into…

…healthcare technology, a busy regulatory environment and evolving consumer demands have combined to shape today’s digital health space. Examining the interplay of those factors can give us a glimpse into…

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Rogers-Headshot
Soapbox

Challenges Faced by Digital Therapeutics Developers

By Brian C. Rogers

…This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success. As a new technological course…

…This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success. As a new technological course…

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FDA CDRH Announces Reopening for All IVD Pre-Submissions

By MedTech Intelligence Staff

On May 31, the FDA Center for Devices and Radiological Health (CDRH) announced that, as of June 1, 2022, CDRH plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions….

On May 31, the FDA Center for Devices and Radiological Health (CDRH) announced that, as of June 1, 2022, CDRH plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions….

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Device Labeling MedAccred

MedAccred Program to Develop Labeling, Printing and UDI Audit Criteria Launched

By MedTech Intelligence Staff

…letters and recalls by driving the adoption of stringent manufacturing process controls. It comes in response to changing and increasingly complex global requirements, which place extra burdens on content management,…

…letters and recalls by driving the adoption of stringent manufacturing process controls. It comes in response to changing and increasingly complex global requirements, which place extra burdens on content management,…

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Mobile apps

AHRQ Releases Technical Brief on Evaluation of Mental Health Apps

By MedTech Intelligence Staff

…apps. The FASTER to Mental Health and Wellness brief comprises three sections: Section 1. Risks and Mitigation Strategies, used to assess the integrity and risk profile of the app. Section…

…apps. The FASTER to Mental Health and Wellness brief comprises three sections: Section 1. Risks and Mitigation Strategies, used to assess the integrity and risk profile of the app. Section…

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Leslie Trigg Outset Medical

Outset Medical CEO Elected MDMA Board Chair

companies, and this dynamic ecosystem is poised to solve some of the most pressing issues facing patient care in the years to come,” said Mark Leahey, president and CEO of…

companies, and this dynamic ecosystem is poised to solve some of the most pressing issues facing patient care in the years to come,” said Mark Leahey, president and CEO of…

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Five Finalists of Annual Pediatric Medical Device Competition Announced

…and create faster pathways to commercialization. We congratulate this year’s finalists and look forward to seeing the progress made in the coming months as they navigate the accelerator program.” The…

…and create faster pathways to commercialization. We congratulate this year’s finalists and look forward to seeing the progress made in the coming months as they navigate the accelerator program.” The…

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Mauricio Uribe

NDAs Remain a Potent Business Tool

By Mauricio Uribe

…has any type of discussion or interaction with external companies (e.g., finance companies, vendor, partners, contractors, etc.). NDAs typically mark the beginning of third-party interactions and will often define the…

…has any type of discussion or interaction with external companies (e.g., finance companies, vendor, partners, contractors, etc.). NDAs typically mark the beginning of third-party interactions and will often define the…

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