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News You Need to Know Today
FDA clears AI-powered imaging software | PE thrombectomy use skyrockets | Startup seeks approval | Bleeding risks & TAVR
Monday, November 10, 2025
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Editor's Choice: Vascular & Endovascular

FDA clears AI-powered vascular imaging software

The new software provides automated measurements that save time and improve the care of aortic aneurysm patients. 

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Nurea PRAEVAorta 2
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FDA clears AI-powered vascular imaging software

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Nurea PRAEVAorta 2
The new software provides automated measurements that save time and improve the care of aortic aneurysm patients. 
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Pulmonary embolism thrombectomy use increases by more than 700%

Medicare claims submitted between 2017 and 2022 showed a 712% increase in thrombectomy for pulmonary embolism (PE) and a 137% increase in thrombectomy for deep vein thrombosis (DVT).

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The Penumbra thrombectomy pulmonary embolism clots extraction catheter displayed at TCT 2025. Photo by Dave Fornell
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Pulmonary embolism thrombectomy use increases by more than 700%

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The Penumbra thrombectomy pulmonary embolism clots extraction catheter displayed at TCT 2025. Photo by Dave Fornell
Medicare claims submitted between 2017 and 2022 showed a 712% increase in thrombectomy for pulmonary embolism (PE) and a 137% increase in thrombectomy for deep vein thrombosis (DVT).
READ MORE >

Shockwave Medical’s IVL catheter for peripheral lesions linked to positive 1-year data

The new findings, presented during a late-breaking presentation, focused on 110 PAD patients treated with Shockwave Medical's Javelin Peripheral IVL Catheter.

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Shockwave Medical Javelin Peripheral IVL Catheter
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Shockwave Medical’s IVL catheter for peripheral lesions linked to positive 1-year data

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Shockwave Medical Javelin Peripheral IVL Catheter
The new findings, presented during a late-breaking presentation, focused on 110 PAD patients treated with Shockwave Medical's Javelin Peripheral IVL Catheter.
READ MORE >

Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

Tulyp Medical, a French medtech startup, has emerged from stealth focused on securing FDA clearance for a patented perfusion device.

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startup business healthcare medtech heart
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Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

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startup business healthcare medtech heart
Tulyp Medical, a French medtech startup, has emerged from stealth focused on securing FDA clearance for a patented perfusion device.
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Cardiologist Peter Soukas becomes chief medical officer of carotid stent company

The company said the move will help it prepare for what is expected to be a rapid expansion of carotid stenting.

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Well-known cardiologist Peter A. Soukas, MD, FACC, FSCAI, FSVM, FACP, has become chief medical officer of carotid stent maker InspireMD Inc.
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Cardiologist Peter Soukas becomes chief medical officer of carotid stent company

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Well-known cardiologist Peter A. Soukas, MD, FACC, FSCAI, FSVM, FACP, has become chief medical officer of carotid stent maker InspireMD Inc.
The company said the move will help it prepare for what is expected to be a rapid expansion of carotid stenting.
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How to minimize bleeding risks after TAVR

Bleeding events remain a serious complication after TAVR. By identifying high-risk patients early and planning ahead, however, care teams can keep them to a minimum.

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
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How to minimize bleeding risks after TAVR

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A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]
Bleeding events remain a serious complication after TAVR. By identifying high-risk patients early and planning ahead, however, care teams can keep them to a minimum.
READ MORE >

FDA approves key update for Medtronic’s Endurant stent graft system

Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.

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Endurant stent graft system labeling
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FDA approves key update for Medtronic’s Endurant stent graft system

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Endurant stent graft system labeling
Going forward, Medtronic can include clinical evidence related to the treatment of ruptured abdominal aortic aneurysms in the device's labeling. This is the first time an EVAR system has received such an approval.
READ MORE >

In Case You Missed It

Florida patient sues hospital, cardiology practice for alleged negligence after leg amputation

The patient alleges she experienced significant delays in care after being rushed to the hospital for acute limb ischemia. She also says no vascular surgeons were available, limiting her treatment options.

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
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Florida patient sues hospital, cardiology practice for alleged negligence after leg amputation

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American Heart Association and Joint Commission launch new Comprehensive Heart Attack Center certification.
The patient alleges she experienced significant delays in care after being rushed to the hospital for acute limb ischemia. She also says no vascular surgeons were available, limiting her treatment options.
READ MORE >

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