Scherdel Medtec NA Achieves ISO 13485 Certification for Enhanced Quality Standards

Muskegon, Michigan, US – April 18, 2024 – Scherdel Medtec North America, part of Scherdel Medtec GmbH, a leading global provider of medical device components, today announced it has achieved certification to the ISO 13485:2016 standard. This internationally recognized standard outlines the requirements for a quality management system (QMS) specific to the medical device industry.…

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TrialAssure Joins NVIDIA Inception

CANTON, Mich. (April 22, 2024) — TrialAssure today announced it has joined NVIDIA Inception, a program that nurtures companies revolutionizing industries with technological advancements.  TrialAssure is a leader in using artificial intelligence (AI) and machine learning (ML) across pharmaceuticals, finance, and government to create technology solutions that meet regulatory compliance goals for clinical trial disclosure, data sharing…

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State R&D Tax Credit to be Reestablished

A package of bills that would reestablish a state research & development (R&D) tax credit in Michigan – HBs 4368, 5099, 5100, 5101 and 5102 – passed by the Michigan Senate in bipartisan fashion 22-13 on March 19, 2024. As proposed, taxpayers and authorized businesses with 250 or more employees could claim up to $2.0…

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A Tribute to a Giant of Michigan’s Biosciences Community

James (Jim) Herbert, who passed away recently, was a founding father of Michigan’s biotechnology ecosystem. He brought to his work, and to his life, a passion, a vision and a perseverance rooted in his belief that biotechnology was the way of the future. In so doing, Herbert co-founded and built Neogen, a pioneering multi-national food…

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TrialAssure Launches Anonymize 3.0 Technology for an Improved Data and Document Anonymization User Experience in Pharma and Beyond

TrialAssure, a leading pharmaceutical technology provider advancing clinical trial disclosure, data sharing, and transparency, announced that its flagship product TrialAssure ANONYMIZE® 3.0 is now available. ANONYMIZE allows users across the pharmaceutical industry the ability to perform data, document, and image anonymization and redaction using machine learning (ML), natural language processing (NLP), and artificial intelligence (AI)…

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90,000 sq. ft. Expansion of Grand River Aseptic Manufacturing’s Finishing and Warehouse Center is Complete

 Grand River Aseptic Manufacturing (“GRAM”), a leading sterile injectable contract manufacturer of biologics, small molecules, and vaccines, announces the completion of its finishing and warehouse center expansion. The expansion added 90,000 sq. ft. to the existing 110,000 sq. ft., totaling 200,000 sq. ft. of sophisticated inspection, packaging, testing, and warehouse capabilities. Grand River Aseptic Manufacturing…

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Cayman Chemical Introduces LipidLaunch™, Expands Portfolio of Lipid Nanoparticle Research Tools to Support Advances in RNA Therapies

ANN ARBOR, MI, FEBRUARY 22, 2024 – Cayman Chemical, a leading supplier of research tools for lipid nanoparticles (LNPs), announced today the introduction of LipidLaunch™ research-ready LNPs and reagent kits. The LipidLaunch™ product line is the latest addition to the company’s portfolio of LNP research tools and reflects the company’s legacy of providing high-quality lipids…

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Michigan Health Information Network Announces Appointment of Janée Tyus to its Board of Directors

Original Source Tyus brings over a decade of experience in advancing health equity, improving access to the Board EAST LANSING, Mich. – The Michigan Health Information Network Shared Services (MiHIN), Michigan’s state designated health information exchange, today announced that Janée Tyus, MPH has been elected to its Board of Directors. Tyus will bring over a decade of…

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TrialAssure Uses Artificial Intelligence to Create Plain Language Summaries for 50,000 Studies Listed on ClinicalTrials.Gov

ORIGINAL SOURCE TrialAssure’s proprietary AI-technology can aid in making clinical trial results available more quickly to all trial participants and the public The equivalent of one million work hours completed in less than one day using AI in honor of Health Literacy Month Plain language summaries to be released over a five-week period by disease…

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AdvaMed Responds to Proposed Rules Governing Ethylene Oxide’s Role in Sterilizing Medtech

ORIGINAL SOURCE WASHINGTON, D.C. – The Environmental Protection Agency (EPA) today released its proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act. The EPA also released its proposed update of EtO registration as a sterilant under the…

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