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News You Need to Know Today
CGM receivers recalled over safety issues | AI for nongated CT scans | Medtronic tech at center of new training center
Thursday, June 19, 2025
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Today's News and Trends

Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.

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Recall | Product recall
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Updated: Dexcom recalls more than 700K CGM receivers over safety issues—dozens of adverse events reported

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Recall | Product recall
There is an increased risk that these devices will not provide audible alerts for low or high blood glucose levels. The FDA has ruled that this is a Class I recall, highlighting the safety risks associated with missed alerts.
READ MORE >

AI model gets helpful heart assessments out of nongated CT scans

"Using AI for tasks like CAC detection can help shift medicine from a reactive approach to the proactive prevention of disease," one researcher said.

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artificial intelligence heart AI
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AI model gets helpful heart assessments out of nongated CT scans

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artificial intelligence heart AI
"Using AI for tasks like CAC detection can help shift medicine from a reactive approach to the proactive prevention of disease," one researcher said.
READ MORE >

Robotic heart surgery represents a key step forward for SS Innovations

The company's SSi Mantra 3 robotic surgery system has already gained regulatory approvals in several countries. FDA approval is anticipated by late 2025 or early 2026.

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SS Innovations International SSi Mantra 3 robotic surgery system
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Robotic heart surgery represents a key step forward for SS Innovations

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SS Innovations International SSi Mantra 3 robotic surgery system
The company's SSi Mantra 3 robotic surgery system has already gained regulatory approvals in several countries. FDA approval is anticipated by late 2025 or early 2026.
READ MORE >

Medtronic technology at center of new hands-on training center for surgeons, interventionalists

The Pearl, a new innovation hub in North Carolina, will soon be home to the first training center of its kind. Many of the advanced technologies on hand will be designed by Medtronic.

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Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
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Medtronic technology at center of new hands-on training center for surgeons, interventionalists

Share on Twitter Share on Facebook Share on Linkedin
Tiny fragments of plastic are commonly found deep inside the human body. Heart surgery, it seems, is one of many ways these microplastics are reaching their destination.  Surgeons Operating On Patient
The Pearl, a new innovation hub in North Carolina, will soon be home to the first training center of its kind. Many of the advanced technologies on hand will be designed by Medtronic.
READ MORE >

Featured Articles

Cardiology societies should develop separate guidelines for treating female heart patients

Janet Wei, MD, examined the key differences between men and women when it comes to cardiovascular disease. These differences, she said, highlight why female patients need their very own treatment guidelines.

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Janet Wei, MD, Erika J. Glazer Chair in Women’s Cardiovascular Research, Education and Innovation at the Smidt Heart Institute at Cedars-Sinai Hospital, explains the key differences between men and women in cardiovascular disease presentations and disease progression. She said heart disease its the number one cause of death in women and the guidelines cannot be a one size fits all document lumping men and women together, they really need to separate out specific details for women.
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Cardiology societies should develop separate guidelines for treating female heart patients

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Janet Wei, MD, Erika J. Glazer Chair in Women’s Cardiovascular Research, Education and Innovation at the Smidt Heart Institute at Cedars-Sinai Hospital, explains the key differences between men and women in cardiovascular disease presentations and disease progression. She said heart disease its the number one cause of death in women and the guidelines cannot be a one size fits all document lumping men and women together, they really need to separate out specific details for women.
Janet Wei, MD, examined the key differences between men and women when it comes to cardiovascular disease. These differences, she said, highlight why female patients need their very own treatment guidelines.
READ MORE >

Late-breaking clinical trials announced for New York Valves 2025

The three-day event is now in its second year. Each day will feature late-breaking clinical trials focused on a different heart valve.

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Statue of Liberty New York City healthcare
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Late-breaking clinical trials announced for New York Valves 2025

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Statue of Liberty New York City healthcare
The three-day event is now in its second year. Each day will feature late-breaking clinical trials focused on a different heart valve.
READ MORE >

Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B

The company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.

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merger acquisition M&A business
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Eli Lilly to acquire gene-editing specialists focused on CVD for up to $1.3B

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merger acquisition M&A business
The company has agreed to acquire Verve Therapeutics for an upfront payment of approximately $1 billion. The total could increase significantly, however, if certain milestones are met. One of Verve's biggest gene therapies has already received the FDA's fast track designation.
READ MORE >

Atraverse Medical raises $29M to support FDA-approved heart tech

The San Diego-based startup gained FDA approval for its Hotwire RF guidewire in 2024. The technology has already been used to perform hundreds of heart procedures.

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money business cash flow dollar. Kingsway Financial Services, a Chicago-based holding company with subsidiaries in several industries, has acquired New Jersey-based Digital Diagnostics Imaging (DDI) for $11 million. The transaction was funded with $5.4 million in cash and $5.6 million in debt financing.
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Atraverse Medical raises $29M to support FDA-approved heart tech

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money business cash flow dollar. Kingsway Financial Services, a Chicago-based holding company with subsidiaries in several industries, has acquired New Jersey-based Digital Diagnostics Imaging (DDI) for $11 million. The transaction was funded with $5.4 million in cash and $5.6 million in debt financing.
The San Diego-based startup gained FDA approval for its Hotwire RF guidewire in 2024. The technology has already been used to perform hundreds of heart procedures.
READ MORE >

In Case You Missed It

Cardiologist became paralyzed after wearing heavy aprons in the cath lab for decades—but he fought back

Dean J. Kereiakes, MD, was left paralyzed after battling severe orthopedic issues for his entire career. Back in the cath lab after a long recovery, he is now stressing the importance of workplace safety among interventional cardiologists.

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Dean Kereiakes, a nationally renowned interventional cardiologist and president of The Christ Hospital Heart and Vascular Institute, has long been recognized for his groundbreaking work in cardiovascular research and intervention. But in 2024, his career and his life were permanently altered when decades of wearing heavy lead protection in the cath lab left him paralyzed.
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Cardiologist became paralyzed after wearing heavy aprons in the cath lab for decades—but he fought back

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Dean Kereiakes, a nationally renowned interventional cardiologist and president of The Christ Hospital Heart and Vascular Institute, has long been recognized for his groundbreaking work in cardiovascular research and intervention. But in 2024, his career and his life were permanently altered when decades of wearing heavy lead protection in the cath lab left him paralyzed.
Dean J. Kereiakes, MD, was left paralyzed after battling severe orthopedic issues for his entire career. Back in the cath lab after a long recovery, he is now stressing the importance of workplace safety among interventional cardiologists.
READ MORE >

Inflammation playing a much bigger role in heart disease evaluations

From new drug therapies and imaging technologies to updated prevention strategies, nearly every aspect of cardiovascular care is starting to embrace the value of coronary inflammation evaluations. Paul Ridker, MD, MPH, discussed the trend in a new interview.

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Paul Ridker, MD, MPH, Eugene Braunwald Professor of Medicine at Harvard Medical School, and Director of the Center for Cardiovascular Disease Prevention, at Brigham and Women’s Hospital, explains the role of high sensitivity C-reactive protein (hs-CRP) in detecting coronary inflammation and the opportunities to improve outcomes with targeted therapies.
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Inflammation playing a much bigger role in heart disease evaluations

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Paul Ridker, MD, MPH, Eugene Braunwald Professor of Medicine at Harvard Medical School, and Director of the Center for Cardiovascular Disease Prevention, at Brigham and Women’s Hospital, explains the role of high sensitivity C-reactive protein (hs-CRP) in detecting coronary inflammation and the opportunities to improve outcomes with targeted therapies.
From new drug therapies and imaging technologies to updated prevention strategies, nearly every aspect of cardiovascular care is starting to embrace the value of coronary inflammation evaluations. Paul Ridker, MD, MPH, discussed the trend in a new interview.
READ MORE >

Private equity-backed cardiology group partners with advanced rounding tech specialists

Cardiovascular Associates of America and cardiologist-founded HybridChart are now working together in a move designed to deliver value-based care to heart patients.

READ MORE >
doctor examines patient data on their tablet
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Private equity-backed cardiology group partners with advanced rounding tech specialists

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doctor examines patient data on their tablet
Cardiovascular Associates of America and cardiologist-founded HybridChart are now working together in a move designed to deliver value-based care to heart patients.
READ MORE >

In Other News

Arizona woman arrested for alleged whole-body imaging scam using veterinary products to treat cancer

Janmarie Lanzo is charged with conspiracy to violate the Food, Drug, and Cosmetic Act and defraud the FDA, according to the indictment. 

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Drugs money scam
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Arizona woman arrested for alleged whole-body imaging scam using veterinary products to treat cancer

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Drugs money scam
Janmarie Lanzo is charged with conspiracy to violate the Food, Drug, and Cosmetic Act and defraud the FDA, according to the indictment. 
READ MORE >

Ivenix infusion kits recalled by FDA due to serious manufacturing defect

Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.

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FDA Recall
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Ivenix infusion kits recalled by FDA due to serious manufacturing defect

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FDA Recall
Lines included in the kits were misassembled and could result in a botched blood transfusion. Due to the risk of serious injury or death, the recall has been designated as Class I.
READ MORE >

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