The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.
Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.
The system is cleared to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal indications.
The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.
Omron Healthcare has received FDA de novo authorization for its IntelliSense blood pressure monitors, which use AI to detect atrial fibrillation with 95% sensitivity and 98% specificity.
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Philips’ Spectral CT 7500 RT, now FDA-cleared, integrates spectral CT into radiotherapy, enhancing tumor visualization and targeting.
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Zeta Surgical’s Zeta Navigation System has received FDA clearance for expanded instruments and enhanced hospital connectivity.
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Paragonix Technologies received FDA 510(k) clearance for KidneyVault, a portable kidney preservation device with digital monitoring.
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Epitel’s REMI Vigilenz AI For Bedside Notifications has received FDA 510(k) clearance, notifying clinicians of potential seizures.
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The FDA approved marketing for CMR Surgical’s Versius Surgical System, designed to assist in minimally invasive soft tissue surgeries.
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Natus Medical submitted an FDA 510(k) notification for its point-of-care EEG device, designed to identify seizures in acute care settings.
