The CE Mark builds on the company’s ISO 13485 certification, further strengthening confidence in the platform's safety, quality and performance
The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE
The initiative will be led by David Baker, 2024 Nobel Prize winner in Chemistry, IPD director, professor of biochemistry, and HHMI Investigator at the University of Washington
LTTS’ lung digital twin integrates seamlessly with CT imaging workflows, using deep learning to reconstruct a comprehensive 3D digital twin of the lungs
Diasens and GlucoLive are designed for diabetic, Chronic Kidney Disease (CKD), and post-transplant patients who require continuous glycaemic surveillance and integrated remote care
Swayam is designed to support elderly patients and their families with seamless access to coordinated medical care
NCFB is a chronic lung condition where damaged airways cause persistent coughing and mucus production
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
The approval is based on the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
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