This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...

Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...

Nia Therapeutics announced publication in Brain Stimulation of the first in vivo validation of its Smart Neurostimulation ...

PMI’s FDA-approved SynCardia STAH is promising, but adoption and revenues lag; cash burn and dilution weigh. Read the full ...

Six days after a senior FDA official sent a sweeping internal email claiming that COVID-19 vaccines had caused the deaths of "at least 10 children," 12 former FDA commissioners released an ...

Abbott’s range of paediatric heart treatments also includes the Masters HP 15mm mechanical heart valve. Credit: Michael Vi / Shutterstock.com. Abbott has secured the US Food and Drug Administration ...

On Monday, the U.S. Food and Drug Administration (FDA) approved Abbott Laboratories’ (NYSE: ABT) Volt PFA System to treat patients battling atrial fibrillation (AFib). AFib is the most common type of ...

Nia Therapeutics announced the publication of the first in vivo validation of its wireless, implantable brain-computer ...

The US Food and Drug Administration (FDA) has granted approval for Abbott’s Volt PFA System, expanding treatment options for patients with atrial fibrillation (AFib). The approval follows earlier CE ...

After claiming its approval in Europe earlier this year, Abbott has secured the FDA’s go-ahead for its Volt pulsed field ablation system for irregular heart rhythms, a step forward in an international ...

Abbott (ABT) announced the U.S. FDA has approved the company’s Volt PFA System to treat patients battling atrial fibrillation. Abbott will soon begin commercial PFA cases in the United States and will ...