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News You Need to Know Today
Previewing TCT 2026 | FDA clears new AI tool | First procedure of its kind performed in US | Intravascular imaging & PCI
Thursday, October 8, 2026
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Editor's Choice: Interventional Cardiology

Late-breaking clinical trials announced for TCT 2026 in San Diego

TCT 2026 will include a full schedule of late-breaking studies focused on minimally invasive interventions, pharmaceutics, structural heart disease and much more.

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TCT late breaking trial presentation in the main arena at TCT 2025. Photo by Michael Walter
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Late-breaking clinical trials announced for TCT 2026 in San Diego

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TCT late breaking trial presentation in the main arena at TCT 2025. Photo by Michael Walter
TCT 2026 will include a full schedule of late-breaking studies focused on minimally invasive interventions, pharmaceutics, structural heart disease and much more.
READ MORE >

FDA clears AI tool for detecting undiagnosed heart valve disease in ECGs

The new software from Chicago-based Tempus AI was designed to identify signs of moderate or severe MR. This is the company's second FDA clearance in the last two months.

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artificial intelligence in cardiology
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FDA clears AI tool for detecting undiagnosed heart valve disease in ECGs

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artificial intelligence in cardiology
The new software from Chicago-based Tempus AI was designed to identify signs of moderate or severe MR. This is the company's second FDA clearance in the last two months.
READ MORE >

Startup behind new heart device partners with medtech incubator

The new device, designed to perform mitral valve repair in patients with functional MR, was co-invented by cardiologist Samir Kapadia, MD, and surgeon Jose Navia, MD.

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An illustration showing how the Mitria Medical Subvalvular Spacer (SVS) helps repair remodeling of the heart that distorts the valve and prevents proper leaflet closure due to functional mitral regurgitation (FMR). Structural Heart, April 2022, https://www.structuralheartjournal.org/article/S2474-8706(22)01273-8/fulltext.
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Startup behind new heart device partners with medtech incubator

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An illustration showing how the Mitria Medical Subvalvular Spacer (SVS) helps repair remodeling of the heart that distorts the valve and prevents proper leaflet closure due to functional mitral regurgitation (FMR). Structural Heart, April 2022, https://www.structuralheartjournal.org/article/S2474-8706(22)01273-8/fulltext.
The new device, designed to perform mitral valve repair in patients with functional MR, was co-invented by cardiologist Samir Kapadia, MD, and surgeon Jose Navia, MD.
READ MORE >

FDA confirms Class I recall for Impella heart pump controllers

Clinicians can continue using these devices as they await a replacement. The FDA first issued an early alert about this issue in August. 

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Recall | Product recall
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FDA confirms Class I recall for Impella heart pump controllers

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Recall | Product recall
Clinicians can continue using these devices as they await a replacement. The FDA first issued an early alert about this issue in August. 
READ MORE >

First heart procedure of its kind performed in US after careful planning

Specialists from the fields of interventional cardiology and cardiac surgery collaborated to perform what is believed to be the first completely catheter-based Fontan procedure in U.S. history. The young patient's recovery was much easier than it would have been otherwise. 

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The Nicklaus Children’s Hospital Heart Institute was the first to perform a completely catheter-based Fontan procedure. Rather than using open-heart surgery to complete the child’s Fontan circulation, the 2-year-old born with a double-outlet right ventricle underwent a catheter-based approach to avoid open-heart surgery.
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First heart procedure of its kind performed in US after careful planning

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The Nicklaus Children’s Hospital Heart Institute was the first to perform a completely catheter-based Fontan procedure. Rather than using open-heart surgery to complete the child’s Fontan circulation, the 2-year-old born with a double-outlet right ventricle underwent a catheter-based approach to avoid open-heart surgery.
Specialists from the fields of interventional cardiology and cardiac surgery collaborated to perform what is believed to be the first completely catheter-based Fontan procedure in U.S. history. The young patient's recovery was much easier than it would have been otherwise. 
READ MORE >

Johnson & Johnson appears to exit LAA closure market, selling heart tech to new startup

Johnson & Johnson is selling key assets related to its Laminar program to a new startup, Jaguar LAA. This comes less than three years after Johnson & Johnson acquired Laminar for $400 million. 

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Johnson & Johnson appears to exit LAA closure market, selling heart tech to new startup

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business handshake
Johnson & Johnson is selling key assets related to its Laminar program to a new startup, Jaguar LAA. This comes less than three years after Johnson & Johnson acquired Laminar for $400 million. 
READ MORE >

FDA approves first sirolimus drug-eluting balloon for in-stent restenosis

The newly approved device from Cordis provides therapy over an extended period of time without leaving a permanent implant behind.

READ MORE >
 The U.S. Food and Drug Administration (FDA) has cleared the Cordis Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR). With this market approval, Cordis is entering the coronary drug-coated balloon market. The device is also the first sirolimus DEB cleared in the U.S.
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FDA approves first sirolimus drug-eluting balloon for in-stent restenosis

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 The U.S. Food and Drug Administration (FDA) has cleared the Cordis Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR). With this market approval, Cordis is entering the coronary drug-coated balloon market. The device is also the first sirolimus DEB cleared in the U.S.
The newly approved device from Cordis provides therapy over an extended period of time without leaving a permanent implant behind.
READ MORE >

Intravascular imaging consistently improves PCI outcomes, new meta-analysis confirms

The team behind this new meta-analysis reviewed data from more than 24,000 patients with a mean age of nearly 65 years old. They identified several benefits to choosing intravascular imaging guidance during PCI over traditional angiography alone.

READ MORE >
Examples of OCT (left) and IVUS (right) images of two different subjects with calcium. Blue arrows denote calcium noted on OCT, red asterisks mark calcium on IVUS
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Intravascular imaging consistently improves PCI outcomes, new meta-analysis confirms

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Examples of OCT (left) and IVUS (right) images of two different subjects with calcium. Blue arrows denote calcium noted on OCT, red asterisks mark calcium on IVUS
The team behind this new meta-analysis reviewed data from more than 24,000 patients with a mean age of nearly 65 years old. They identified several benefits to choosing intravascular imaging guidance during PCI over traditional angiography alone.
READ MORE >

Laser IVL system for CAD impresses in first-in-human study

FastWave Medical's laser intravascular lithotripsy system successfully fractured calcified coronary artery lesions in 30 patients.

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The Fastwave Sola laser IVL system energy burst to break up coronary calcium.
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Laser IVL system for CAD impresses in first-in-human study

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The Fastwave Sola laser IVL system energy burst to break up coronary calcium.
FastWave Medical's laser intravascular lithotripsy system successfully fractured calcified coronary artery lesions in 30 patients.
READ MORE >

Cardiologists, heart surgeons support push to make postgraduate medical training more affordable

If passed, new bipartisan legislation would allow eligible residents and interns to defer interest accrual on any federal student loans during their required postgraduate training. The bill has support from more than 40 U.S. healthcare organizations, including SCAI, ACC and STS.

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healthcare money economics dollar stethoscope acquire merger
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Cardiologists, heart surgeons support push to make postgraduate medical training more affordable

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healthcare money economics dollar stethoscope acquire merger
If passed, new bipartisan legislation would allow eligible residents and interns to defer interest accrual on any federal student loans during their required postgraduate training. The bill has support from more than 40 U.S. healthcare organizations, including SCAI, ACC and STS.
READ MORE >

In Case You Missed It

SCAI asks ABIM to rethink policy on PCI volume reporting requirements

Procedural volume reporting requirements for PCI are no longer necessary, according to SCAI and its members. Those requirements made sense when PCI was new, but that was many years ago. 

READ MORE >
Simpsons Interventions, a California-based healthcare technology company, has received the FDA’s breakthrough device designation for its Acolyte Image Guided Crossing and Re-Entry Catheter System. SCAI released the list of its late-breaking clinical study trials at its 2022 annual meeting. #SCAI #SCAI22 #SCAI2022
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SCAI asks ABIM to rethink policy on PCI volume reporting requirements

Share on Twitter Share on Facebook Share on Linkedin
Simpsons Interventions, a California-based healthcare technology company, has received the FDA’s breakthrough device designation for its Acolyte Image Guided Crossing and Re-Entry Catheter System. SCAI released the list of its late-breaking clinical study trials at its 2022 annual meeting. #SCAI #SCAI22 #SCAI2022
Procedural volume reporting requirements for PCI are no longer necessary, according to SCAI and its members. Those requirements made sense when PCI was new, but that was many years ago. 
READ MORE >

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