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FDA clears new software for mitral valve repair | AI-powered CCTA assessments vs. IVUS | Safety in the cath lab

News You Need to Know Today
FDA clears new software for mitral valve repair | AI-powered CCTA assessments vs. IVUS | Safety in the cath lab
Tuesday, April 7, 2026
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Editor's Choice: Cardiac Imaging

FDA clears new AI software for mitral valve repair

Philips worked closely with Edwards Lifesciences to develop the new software.

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Philips has secured U.S. Food and Drug Administration (FDA) clearance for EchoNavigator R5.0 with DeviceGuide, the company’s artificial intelligence (AI)-enabled software for mitral transcatheter edge-to-edge repair (M-TEER).
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FDA clears new AI software for mitral valve repair

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Philips has secured U.S. Food and Drug Administration (FDA) clearance for EchoNavigator R5.0 with DeviceGuide, the company’s artificial intelligence (AI)-enabled software for mitral transcatheter edge-to-edge repair (M-TEER).
Philips worked closely with Edwards Lifesciences to develop the new software.
READ MORE >

AI-powered CCTA assessments show ‘close agreement’ with IVUS

Advanced AI software developed by Cleerly consistently produced plaque assessments comparable to intravascular ultrasound. 

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Example of an automated artificial intelligence (AI) assessment of soft coronary plaque from a CT scan from the vendor Cleerly. This image shows the AI's reconstruction of a patient's coronary tree and color codes the vessel segments by the amount of overall plaque burden. The AI gives a very detailed report of all the plaque in all the coronary vessels. Some cardiology experts believe this may be the way of the future in screening patients for early coronary disease and monitoring the impact of prevention
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AI-powered CCTA assessments show ‘close agreement’ with IVUS

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Example of an automated artificial intelligence (AI) assessment of soft coronary plaque from a CT scan from the vendor Cleerly. This image shows the AI's reconstruction of a patient's coronary tree and color codes the vessel segments by the amount of overall plaque burden. The AI gives a very detailed report of all the plaque in all the coronary vessels. Some cardiology experts believe this may be the way of the future in screening patients for early coronary disease and monitoring the impact of prevention
Advanced AI software developed by Cleerly consistently produced plaque assessments comparable to intravascular ultrasound. 
READ MORE >

Cardiologists lead push for new cath lab radiation safety standards

Several U.S. medical societies have collaborated on a new report advocating for better safety standards in cardiac catheterization labs. As one cardiologist described it, clinicians have shifted from "accepting risk" to "expecting better."

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Heart doctors and surgeons working together. Top cardiology hospitals in the United States.
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Cardiologists lead push for new cath lab radiation safety standards

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Heart doctors and surgeons working together. Top cardiology hospitals in the United States.
Several U.S. medical societies have collaborated on a new report advocating for better safety standards in cardiac catheterization labs. As one cardiologist described it, clinicians have shifted from "accepting risk" to "expecting better."
READ MORE >

Shortage of cardiac amyloidosis radiotracers should ease in late March

However, the regular supply of these imaging radiotracers may not be back online for another few months.

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cardiac amyloidosis on bone scan. Image courtesy of the Department of Nuclear Medicine, Medical University of Vienna, Austria.
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Shortage of cardiac amyloidosis radiotracers should ease in late March

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cardiac amyloidosis on bone scan. Image courtesy of the Department of Nuclear Medicine, Medical University of Vienna, Austria.
However, the regular supply of these imaging radiotracers may not be back online for another few months.
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9 ways cardiovascular IT systems can improve your day-to-day workflow

Bringing in a new and improved cardiovascular IT system can save physicians a ton of time and lead to considerable cost savings.

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Workflow efficiencies and automation enhance newer cardiovascular IT systems
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9 ways cardiovascular IT systems can improve your day-to-day workflow

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Workflow efficiencies and automation enhance newer cardiovascular IT systems
Bringing in a new and improved cardiovascular IT system can save physicians a ton of time and lead to considerable cost savings.
READ MORE >

FDA clears intravascular device billed as ‘world’s smallest camera’ as physicians share new data

The new device, which provides users with real-time images in full color, is now approved by the FDA to be used in the peripheral vasculature. Meanwhile, first-in-human data published in Stroke explored its potential in the cerebral vasculature. 

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Selection of stent images captured with the MicroAngioscope from Vena Medical. Images courtesy of Kan et al. and Stroke.
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FDA clears intravascular device billed as ‘world’s smallest camera’ as physicians share new data

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Selection of stent images captured with the MicroAngioscope from Vena Medical. Images courtesy of Kan et al. and Stroke.
The new device, which provides users with real-time images in full color, is now approved by the FDA to be used in the peripheral vasculature. Meanwhile, first-in-human data published in Stroke explored its potential in the cerebral vasculature. 
READ MORE >

FDA clears AI-enabled cardiac MR planning technology from Philips

The new SmartHeart technology automates 14 cardiac views in less than 30 seconds. It was designed to increase productivity and bring more consistency to cardiology and radiology departments.

READ MORE >
Philips has secured U.S. Food and Drug Administration (FDA) clearance for SmartHeart, the company’s new artificial intelligence (AI)-powered planning technology for cardiac MR (CMR) exams.
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FDA clears AI-enabled cardiac MR planning technology from Philips

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Philips has secured U.S. Food and Drug Administration (FDA) clearance for SmartHeart, the company’s new artificial intelligence (AI)-powered planning technology for cardiac MR (CMR) exams.
The new SmartHeart technology automates 14 cardiac views in less than 30 seconds. It was designed to increase productivity and bring more consistency to cardiology and radiology departments.
READ MORE >

Imaging evaluations and PCI planning: Heartflow announces ‘tremendous progress’ for AI portfolio

Heartflow's AI technologies are at the center of multiple ACC.26 presentations. In addition, the company announced, the first patient was enrolled into the NAVIGATE-PCI registry.

READ MORE >
Heartflow PCI Navigator Cardiology. PCI Navigator from Heartflow was designed to help cardiologists plan ahead for percutaneous coronary interventions before they even step foot into the cath lab. It assesses a patient’s CCTA results and creates a state-of-the-art 3D model.
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Imaging evaluations and PCI planning: Heartflow announces ‘tremendous progress’ for AI portfolio

Share on Twitter Share on Facebook Share on Linkedin
Heartflow PCI Navigator Cardiology. PCI Navigator from Heartflow was designed to help cardiologists plan ahead for percutaneous coronary interventions before they even step foot into the cath lab. It assesses a patient’s CCTA results and creates a state-of-the-art 3D model.
Heartflow's AI technologies are at the center of multiple ACC.26 presentations. In addition, the company announced, the first patient was enrolled into the NAVIGATE-PCI registry.
READ MORE >

In Case You Missed It

MRI scans evaluate heart failure risk—no invasive catheterization required

Advanced imaging may be able to help certain heart patients avoid the risks and discomfort associated with right heart catheterizations.

READ MORE >
Researchers in the U.K. from Newcastle University, University of Leeds, and the University of East Anglia found they could use cardiovascular magnetic resonance (CMR) T2 intracardiac blood pool data to create imaging-derived SvO2 (iSvO2) noninvasively.
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MRI scans evaluate heart failure risk—no invasive catheterization required

Share on Twitter Share on Facebook Share on Linkedin
Researchers in the U.K. from Newcastle University, University of Leeds, and the University of East Anglia found they could use cardiovascular magnetic resonance (CMR) T2 intracardiac blood pool data to create imaging-derived SvO2 (iSvO2) noninvasively.
Advanced imaging may be able to help certain heart patients avoid the risks and discomfort associated with right heart catheterizations.
READ MORE >

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