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Tag: medical device

Global Biopharma R&D Boasts Increased Funding, Productivity and Product Launches in 2023, says IQVIA Institute Report

Clinical development productivity rose in 2023, primarily due to an improvement in the composite success rate, a function of phases successfully completed in the...

Elon Musk Says First Neuralink Patient Can Move Computer Cursor With Mind

Neural interfaces could present an entirely new way for humans to connect with technology. Elon Musk says the first human user of his startup...

MDCG Guidance on Clinical Investigations: Content and Modifications | EU

The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it. Table of...

Serbian Guidance on Amendments to MD Registration: Overview | Serbia

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

Medical Device Companies Annual Self-Inspection Report Due March 31

All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 “Medical...

IQVIA CFO Ron Bruehlman to Speak at Citi’s Unplugged Medtech and Life Sciences Access Day on February 29, 2024

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–IQVIA Holdings Inc. (“IQVIA”) (NYSE:IQV), announced today that Ron Bruehlman, executive vice president and chief financial officer, will speak at...

FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury | BioSpace

SCD-PED (Pediatric) is the first FDA-approved product in the Company’s Quelimmune™ product family DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:...

EVŌQ Nano Announces That Its Antimicrobial Medical Device Platform Demonstrates Success Against the Leading Cause of Healthcare-Associated Infections | BioSpace

Novel Nanoparticle Platform Shows Efficacy Against Antimicrobial Resistance; Potential to Disrupt the $29 Billion Catheter Market SALT LAKE CITY, Feb. 22, 2024 /PRNewswire/ --...

FDA Draft Guidance on Third-Party Review: 3P510k Eligibility Factors | United States

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

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