The innovations extend deep learning reconstruction and photon-filtering technology to a broader range of CT imaging applications, including lung and musculoskeletal scans.
KomodoSec aided a life-support device maker in overcoming cybersecurity and regulatory hurdles to achieve FDA 510(k) approval.
Paragonix Technologies received FDA 510(k) clearance for KidneyVault, a portable kidney preservation device with digital monitoring.
The innovations extend deep learning reconstruction and photon-filtering technology to a broader range of CT imaging applications, including lung and musculoskeletal scans.
Siemens Healthineers has received U.S. FDA clearance for the AI-powered Acuson Origin cardiovascular ultrasound system and the AcuNav Lumos 4D ICE catheter, both designed to improve cardiac diagnostics and patient care.
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The Masimo W1 medical watch received FDA clearance for connectivity, enabling integration with the Masimo SafetyNet telemonitoring solution.
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Diality has received U.S. FDA 510(k) clearance for its Moda-flx Hemodialysis System, designed to support various dialysis treatments and improve usability across multiple care settings.
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Varian received FDA 510(k) clearance for its IntelliBlate microwave ablation system, designed for soft tissue ablation.
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Positrigo, a Swiss company, received FDA clearance for its NeuroLF brain PET system, designed to diagnose and monitor brain disorders.
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ImmersiveTouch has received FDA clearance for its ImmersiveAR platform, an augmented reality technology to enhance surgical planning.
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Blue Goat Cyber expanded its pre- and post-market cybersecurity services for medical devices, helping manufacturers navigate FDA regulations.
