BioProcess International

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in GxP Environments

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...

Compliance Group Reveals iQuality, an AI-Native End-to-End Compliance Intelligence Solution for Life Sciences

Compliance Group (CG), a trusted leader in quality, validation, compliance, and digital transformation services for regulated ...
MD&M East

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...
Morningstar

Penumbra's THUNDERBOLT Receives FDA Clearance - Bringing Computer Assisted Vacuum Thrombectomy Technology to Stroke

THUNDERBOLT is the first CAVT platform to deliver modulated aspiration for acute ischemic stroke — enabling faster, more complete clot removal "Stroke is the second leading cause of death worldwide ...
Healio

FDA approves updated Spectralis retinal imaging software

Please provide your email address to receive an email when new articles are posted on . The update adds 250 kHz scan speed for OCT angiography and green autofluorescence for macular imaging. The ...
complianceg

Modern Compliance in Regulated Life Sciences: The Complete Guide to CSA, AI Governance, and Intelligent Quality Management

For quality leaders navigating FDA’s CSA guidance, AI governance requirements, and the pressure to modernize without breaking compliance—this is the guide that ...
Reuters

US FDA issues recall of Boston Scientific heart devices

May 7 (Reuters) - Boston Scientific (BSX.N), opens new tab has issued an urgent recall to correct several heart devices after the U.S. Food and Drug Administration classified the action as its ‌most ...
Morningstar

Avatar Medical Receives FDA 510(k) Clearance for Avatar Medical Vision, the First Software Cleared for Use with Glasses-Free 3D Medical Displays

Avatar Medical Vision enables clinicians to process and interact with CT and MR imaging data as spatial, multi-dimensional representations across standard operating room displays, glasses-free 3D ...