FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
vator25d
The FDA outlines draft guidance on AI for medical devices
AI is touching every industry, and healthcare is no exception: the global market size for healthcare AI, which was valued at ...
JD Supra16d
FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know
Transparency is also emphasized to ensure better usability of AI-enabled medical devices. Bias Control. The FDA’s bias control concerns focus on minimizing demographic biases in training data to ...
FDA Authorizes Myocene Device for Muscle Fatigue Monitoring and Informed Training Decisions
Myocene’s unique patented technology relies on decades of scientific research and combines high precision electrostimulation and force sensing to obtain a fatigue index in just two minutes. Tailored ...
medtechdive9d
Irish Neurotech Start-up, CergenX Receives FDA Breakthrough Designation for Wave Device
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...
medtechdive28d
FDA closes 2024 with string of early alerts on device safety risks
In the final days of 2024, the Food and Drug Administration ... through a vascular access device such as an infusion pump. The slide clamp is designed to shut off fluid flow and load the set into the ...
Medical Design and Outsourcing6d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
Becker's Hospital Review8d
FDA's plan to tackle medical device shortages: 4 notes
To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...
JD Supra8d
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...